MEDTRONIC SOFAMOR DANEK USA, INC.

FDA Device Registration & Listing · Memphis, TN, US · Registration 3003120897

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3003120897
FEI Number
3003120897
Entity Name
MEDTRONIC SOFAMOR DANEK USA, INC.
City/State/Country
Memphis, TN, US
Establishment Address
4340 Swinnea Road, Memphis, TN 38118, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Medtronic, Inc. (Owner Number: 2112641)
Owner / Operator Contact Address
710 Medtronic Parkway, Minneapolis, MN 55432, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K111520
PMA Number
N/A

All Registered Proprietary Names

Kyphon Mixer Atrion Inflation Syringe CD Horizon™ Spinal System INFINITY™ Occipitocervical Upper Thoracic System Catalyft™ LS Expandable Interbody System OsteoCool™ 2 RF Ablation System General Instruments CD Horizon Spinal System CD HORIZON Spinal System MUTIPLE TYPES OF BURS MICRO-FRANCE CD HORIZON® Fenestrated Screw Set CD HORIZON SEXTANT II Spinal System CD HORIZON Spinal System PEAK PlasmaBlade 3S (Model Number: PS210-030S, PS210-030S-SP, PS210-030SE) CD HORIZON Fenestrated Screw Set Kyphon HV-R Fenestrated Screw Cement Dyna-lok/Danek Plate Screw TSRH Spinal System STEALTH AXIS™ ATLANTIS- Anterior Cervical Plate System Atrion Inflation Syringe SHILLA(TM) Growth Guidance System CAPSTONE Spinal System Medtronic Transportation/Sterilization Cassettes Curette MULTIPLE (SURGICAL MALLETS) Crescent Spinal System Interbody F CD HORIZON® SOLERA® Spinal System ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS" Anterior Cervical Plate System INFINITY™ OCT System INFUSE BONEGRAFT Tibial Fracture ZEVO Anterior Cervical Plate System ORTHOPEDIC (ORTHOPEDIC MANUAL SURG ICAL INST) HOLDER, NEEDLE Medtronic Reusable Instruments CD Horizon™ ModuLeX™ Spinal System POWEREASE System Working Ends CD Cannulated Screw CD Sextant II Reduction ENDOSKELETON® TA nanoLOCK® Surface Technology Pyramid Tapered Shank Bone Screw Soveriegn Spinal System CD HORIZON Spinal System Catalyft™ PL Expandable Interbody System CD Spire Spikes Medtronic Reusable Instrument MAST QUADRANT™ Retractor System Medtronic Transportation_Sterilization Cassettes SHILLA™ Growth Guidance System Catalyft™ LS Expandable Interbody System MULTIPLE (ORTHOPEDIC REAMERS) CD HORIZON Longitude 2 Instruments and Rods CD HORIZON® Spinal System VERTEX® Reconstruction System BRYAN Cervical Disc CD HORIZON SPIRE(TM) Z Spinal System NAVIGATED INFINITY™ Instruments MULTIPLE (DEPTH GAUGES) Anteralign™ Spinal System with Titan NanoLOCK™ Surface Technology Navigated Instruments TSRH Crosslink System Fuse Spinal System Kyphon Xpede Bone Cement Medtronic Reusable Instrument PEAK PlasmaBlade Tonsil (PS300-001, PS300-001E, PS300-003, SP300-003E) CD HORIZON Spinal System, CD HORIZON ESSENTIALS" Spinal System CD Horizon® Spinal System Zephir Anterior Cervical Plate System Zephir Anterior Cervical Plate PERIMETER INSERTER PrimeAdvanced SureScan MRI Neurostimulator Injex Bumpy Anchor Pisces-Quad Plus Lead N'Vision Software Application Card Specify SureScan MRI Lead Pisces-Quad Compact Lead Resume II Lead RestoreUltra SureScan MRI Neurostimulator Itrel 4 Neurostimulator Resume TL Lead Titan Anchor RestoreSensor Neurostimulator Itrel 4 Neurostimulation System Stretch Coil Extension RestoreAdvanced Neurostimulator EZ Anchor Injex BiWing Anchor RestoreAdvanced SureScan MRI Neurostimulator Specify Lead Vectris SureScan Lead RestorePrime Neurostimulator Itrel EZ Programmer Synergy EZ Programmer RestoreUltra Neurostimulator RestoreSensor SureScan MRI Neurostimulator PrimeAdvanced Neurostimulator myStim Programmer N'Vision Programmer Intellis™ with AdaptiveStim™ Implantable Neurostimulator Vanta™ with AdaptiveStim™ Implantable Neurostimulator Inceptiv™ LT Implantable Neurostimulator Inceptiv™ Implantable Neurostimulator Intellis™ Pro Implantable Neurostimulator HOLDER, NEEDLE ICAL INST) HOLDER NEEDLE ORTHOPEDIC (ORTHOPEDIC MANUAL SURG CD Horizon™ ModuLeX™ Spinal System Rasp Clydesdale Spinal System SOVEREIGN Spinal System VERTEX® Reconstruction System CD HORIZON® Spinal System Navigated CD HORIZON SOLERA Screwdrivers and Taps CD HORIZON SOLERA Spinal System T2 Altitude 1.5 Spinal System InterStim II Neurostimulator Verify External Neurostimulator InterStim Therapy System Verify Controller Verify Evaluation System N'Vision Software Application Card InterStim iCon Programmer N'Vision Programmer InterStim Micro™ Implantable Neurostimulator InterStim™ SureScan™ MRI leads InterStim™ X Implantable Neurostimulator Endoskeleton TAS Plate ELEVATOR CD Horizon™ Astute™ Spinal System SCREWDRIVER DIVERGENCE(TM) Anterior Cervical Fusion System CD HORIZON® Spinal System CD Horizon™ Modular 5.5/6mm Spinal System ORION Anterior Cervical ANTERIOR CERVICAL PLATE SYSTEM Verte-Stack Crescent VERTEX® Reconstruction System CD HORIZON® Spinal System ENDOSKELETON TC CAPSTONE CONTROL Spinal System CAPSTONE CONTROL PTC Spinal System Manual surgical instrument for general use Slap Hammer Verte-Stack Modified Cornerstone Perimeter Interbody Fusion Device Centerpiece Plate Fixation System CAPSTONE Spinal System Navigated Disc Prep Instruments PRESTIGECervical Disc BRYANCervical Disc System Spinal System ENDOSKELETON(R) TAS T2 Sceptor Universal Endcleats Advisa DR MRI SureScan Advisa DR Adapta InCheck Patient Assistant Relia IPG Adapta L Adapta S Advisa SR MRI SureScan Versa DR IPG Sensia DR IPG Azure XT DR MRI Azure S SR MRI Azure XT SR MRI Azure S DR MRI CareLink SmartSync Azure Astra Application Sphera DR MRI Attesta L DR MRI Attesta SR MRI Attesta S DR MRI Attesta DR MRI Sphera SR MRI Sphera L DR MRI Sensia IPG T2 TXVBR MICRO-FRANCE MULTIPLE (SCISSORS) Anatomic Peek PTC Cervical Fusion System Cage Expandable Cage Wave O Spinal System CD HORIZON® Spinal System CD Modified Sextant II Instruments Adaptor Extender Kit Sprint Quattro Secure MRI SureScan Lead DF-1 Port Pin Plug Subcutaneous Lead Tunneling Tool Sprint Quattro Secure S MRI SureScan Lead Sprint Quattro Secure S Lead Sprint Quattro MRI SureScan Lead Sprint Quattro Lead Transvene Lead Transvene SVC Lead Adaptor Kit IS-1 Port Pin Plug Kit Sprint Quattro Secure Lead CD Horizon™ ModuLeX™ FNS Screw Set CD Horizon™ ModuLeX™ Spinal System NIM Eclipse PIVOX" Oblique Lateral Spinal System Medtronic Reusable Instrument ZPlate II Activa Tremor Control Therapy Access Therapy Controller Activa RC Neurostimulator Activa PC Neurostimulator N'Vision Software Application Card StimLoc Activa SC Neurostimulator DBS Extension Kit Access Review Therapy Controller N'Vision Programmer Activa Parkinsons Control Therapy Intercept™ Percept™ PC BrainSense™ SenSight™ Percept™ RC Rechargeable Neurostimulator with BrainSense™ Technology CD HORIZON ESSENTIALS™ Spinal System CD HORIZON ESSENCE CapSureFix MRI SureScan Lead Revo MRI SureScan LEGEND Power Adapter Loop Spinal System/ TLIF- Cage Vertex Lateral Connectors Vertex Reconstruction System Verte-Stack Cornerstone Sm End Caps DIVERGENCE Anterior Cervical Fusion System Kyphon Anchor Facet Screw System TSRH Spinal System Prebent/precut r DIVERGENCE Anterior Cervical Fusion System METRx Endoscope Navigated Elevate Spinal System CD HORIZON® Fenestrated Screw Set CD Horizon MAS Design Enhancement Sovereign Robotic Graft Delivery Instruments PEAK PlasmaBlade Needle (Model Number: PS200-001, PS200-001-SP, PS200-001E, PS200-001SPE) T2 STRATOSPHERE™ Expandable Corpectomy System Medtronic Reusable Instrument Vertex Reconstruction System Micra Transcatheter Pacemaker System Micra TPS Micra AV TPS Micra AV2 TPS Micra VR2 TPS Navigated Vertex Select Drill Bit Navigated Vertex Select Threaded Driver Navigated Vertex Select Tap spinal system CD HORIZON Growth Rod Conversion Set Anteralign™ Spinal system with Titan nanoLOCK™ Surface Technology Kyphon Xpander II Inflatable Bone Tamp Viva Quad S CRT-D Claria MRI Quad CRT-D Amplia MRI CRT-D SureScan Concerto II CRT-D Viva S CRT-D Consulta ICD Brava Viva Maximo II CRT-D Protecta XT CRT-D Brava Quadripolar CRT-D Viva Quad XT CRT-D Protecta CRT-D Consulta DF4 ICD Compia MRI Quad CRT-D SureScan Compia MRI CRT-D SureScan Viva XT CRT-D Amplia MRI Quad CRT-D SureScan Concerto ICD Claria MRI CRT-D Crome HF CRT-D MRI SureScan Crome HF Quad CRT-D MRI SureScan Cobalt XT HF Quad CRT-D MRI SureScan Cobalt HF Quad CRT-D MRI SureScan Cobalt XT HF CRT-D MRI SureScan Cobalt HF CRT-D MRI SureScan CRESCENT Vertebral Body Spacer CD HorizonSpinal System MULTIPLE (DRIVER-EXTRACTORS) IB3D™ PL Spinal System Chisel, Surgical, Manual Sovereign Spinal System PROBE (ORTHOPEDIC MANU CD Horizon™ ModuLeX™ Spinal System CD Horizon Solera 5.5/6 Sagittal Adjusting Screws Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device spinal system CD HORIZON Spinal System TSRH CD Perc Trauma CAPSTONE-L SPINAL SYSTEM Pyramid +4 Anterior Lumbar Plate CD HORIZON® Spinal System VERTEX® Reconstruction System CD Horizon SMA Staple Lever Screwdriver KyphX Latitude Curette KyphX Osteointroducer ACPii Atlantis Cervial Plate NO 8 HEXALOBE STRAIGHT DRIVER TRAY, SURGICAL PEEK Previal Cervical Interbody Dev NETTERVILLE LARYNGOLOPLASTIC STAGE TOWEL GRIP CLIP - CLIP MULTIPLE (ORTHOPEDIC CLAMPS) ENDOSKELETON® TA nanoLOCK® Surface Technology CD Sextant Instruments TSRH L Rod Connector Atlas Cable ARTHROSCOPE Kyphon TRANSLACE™ Spinal Tethering System HV-R Bone Cement US Bone Cement HV-R w/Mixer - US Medtronic Reusable Instrument Kyphon Express Inflatable Bone Tamp Inflate FX Fracture Management Inflatable Bone Tamp Kyphon Exact Inflatable Bone Tamp Verte-Stack Perimeter XS Medtronic Reusable Instrument SPINE PLATE LAMINOPLASTY Tissue Approximating Forceps FORCEPS (MANUAL INSTRU MULTIPLE FORCEPS CRESENT Ti Spinal System Navigated Anterolateral Disc Prep Insturments ARTiC-L™ 3D Ti Spinal System with TiONIC™ Technology CD HORIZONSPINAL SYSTEM Medtronic Reusable Instrument IB3D™ PL Spinal System Accurian™ Vantage Plates CD HORIZON® SOLERA® Spinal System Spinal System Capstone Spinal System MULTIPLE TWIST Drill; Introducer Tool MICRO-FRANCE BIT DRILLS DRILL BIT (ORTHOPEDIC MA T2 STRATOSPHERE™ Expandable Corpectomy System MEROCEL SPONGE MICRO-FRANCE Medtronic Dissector Tool CD HORIZON Spinal System Medtronic General Instrument MSB-Perimeter System GoldenEye Micro-Magnetic Tracking WRENCH Container VERTE-STACK Spinal System CD HORIZON(R) Spinal System Wire Caddy BONE SCREW RULER Radio-Opaque Scale MICRO-FRANCE CD Horizon Spinal System MULTIPLE (CHISELS OSTEOTOMES) CD Horizon™ ModuLeX™ Spinal System CLYDESDALE Spinal System PRESTIGE LP Cervical Disc System TSRH Expanded Pedicle Screw Pyramid Non-constrained Cover Plate Clydesdale Spinal System T2 STRATSOPHERE™ Expandable Corpectomy System CD HORIZON® Spinal System Danek Unit Rod BONE HOOK MICRO-FRANCE Catalyft PL Expandable Interbody System Medtronic Reusable Instrument ENDOSKELETON(R) TL INTERBODY FUSION DEVICE CD HORIZON® Spinal System TEMPLATE ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) Kyphon VuE Bone Cement and Kyphon Mixer Pack MEDTRONIC REUSABLE INSTRUMENTS FOR USE WITH THE IPC POWEREASE" SYSTEM Capstone Control™ Spinal System INFUSE BONEGRAFT/ LT-CAGE Lumbar TF General Instrument PASS LP Spinal System ROD BENDER Anteralign™ Spinal system with Titan nanoLOCK™ Surface Technology RIALTO™ SI Fusion System POWEREASE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2008-02-25
DXT Injector And Syringe, Angiographic Cardiovascular Class 2 870.1650 2021-08-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-11-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-11-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-11-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-02-19
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-02-19
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2024-11-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-11-14
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-02-29
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2021-09-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-02-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-02-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-02-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-02-18
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2016-02-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-02-18
EQJ Bur, Ear, Nose And Throat Ear, Nose, Throat Class 1 874.4140 2003-05-08
HXZ Cutter, Wire Orthopedic Class 1 888.4540 1992-12-12
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2020-02-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-02-07
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2020-02-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-02-28
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-02-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-02-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-02-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-02-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-02-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-03-28
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2016-03-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-11-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2009-11-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-11-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-11-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-11-06
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-03-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-07-18
FMF Syringe, Piston General Hospital Class 2 880.5860 2021-08-02
PGM Growing Rod System Orthopedic Class 2 888.3070 2014-07-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2008-05-08
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2016-02-10
HTF Curette General, Plastic Surgery Class 1 878.4800 2005-05-31
HXL Mallet General, Plastic Surgery Class 1 878.4800 2005-05-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2010-05-20
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-06-13
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2017-03-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-03-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-03-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-03-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-03-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-15
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-11-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-11-21
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-10
MPW Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction Unknown Class 3 N/A 2008-03-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-02-12
HXK Holder, Needle; Orthopedic Orthopedic Class 1 888.4540 2006-06-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-06-12
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2013-02-28
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2013-02-28
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2013-02-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-31
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-01-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-26
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-01-26
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-01-26
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-01-26
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-01
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2012-08-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-12-02
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-12-02
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-12-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-12-02
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-12-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-06-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2021-06-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
KTZ Caliper Orthopedic Class 1 888.4150 2010-02-22
GAD Retractor General, Plastic Surgery Class 1 878.4800 2008-02-04
FSZ Light, Surgical, Carrier General, Plastic Surgery Class 2 878.4580 2008-02-04
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2008-02-04
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2020-10-14
HTO Reamer Orthopedic Class 1 888.4540 2005-05-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-10-22
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-10-22
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2012-10-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-10-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-10-22
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-10-22
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2008-03-31
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2012-12-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-12-10
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2012-12-10
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-12-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-02-16
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2005-05-31
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-10
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-08-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-07-19
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2017-02-06
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2005-05-31
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-12-15
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-12-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-12-15
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-12-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-15
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-12-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-10-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-10-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2019-10-28
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2019-10-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-10-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2019-10-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-02-27
LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown Class 3 N/A 2007-12-06
QRB Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy Unknown Class 3 N/A 2007-12-06
HWK Trephine Orthopedic Class 1 888.4540 2006-06-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-08-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-08-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-08-02
HTR Rasp General, Plastic Surgery Class 1 878.4800 2005-05-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2010-07-28
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2009-11-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2014-06-05
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2014-06-05
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2010-11-19
QON Implanted Electrical Device Intended For Treatment Of Fecal Incontinence Gastroenterology, Urology Class 3 876.5270 2011-04-21
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2019-09-06
HTE Elevator General, Plastic Surgery Class 1 878.4800 2005-05-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-10-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-10-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-10-18
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2019-10-18
HXX Screwdriver Orthopedic Class 1 888.4540 1992-12-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-08-10
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-08-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-10-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-10-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-10-12
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2020-10-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-10-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-14
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-02
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-11-06
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 1994-11-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-08-04
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2021-12-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-01-24
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2015-09-14
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2015-03-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-06-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown Class 3 N/A 2007-01-24
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2007-01-24
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2007-01-24
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2007-01-24
DXY Implantable Pacemaker Pulse-Generator Cardiovascular Class 3 870.3610 2007-01-24
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2005-05-31
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-05-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-06-11
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-09-22
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2017-09-22
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-09-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-09-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-09-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2008-01-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-31
NVY Permanent Defibrillator Electrodes Unknown Class 3 N/A 2008-03-12
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2008-03-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-02-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-02-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-02-08
GXZ Electrode, Needle Neurology Class 2 882.1350 2013-11-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2016-01-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-01-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-01-14
HXQ Crimper, Pin Orthopedic Class 1 888.4540 2002-11-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-30
MBX Stimulator, Thalamic, Epilepsy, Implanted Unknown Class 3 N/A 2006-01-18
MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor Unknown Class 3 N/A 2006-01-18
NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms Unknown Class 3 N/A 2006-01-18
PJS Stimulator, Electrical, Implanted, For Essential Tremor Unknown Class 3 N/A 2006-01-18
SGS Deep Brain Stimulation For The Treatment Of Dystonia Unknown Class 3 N/A 2006-01-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-02-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-02-12
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-02-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-02-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-02-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-02-12
LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown Class 3 N/A 2011-02-10
NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown Class 3 N/A 2011-02-10
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2011-02-10
HBB Motor, Drill, Pneumatic Neurology Class 2 882.4370 2010-11-19
GET Motor, Surgical Instrument, Pneumatic Powered General, Plastic Surgery Class 1 878.4820 2010-11-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-06-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-26
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2014-10-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-10-10
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2010-11-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-02-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-02-13
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-02-13
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2015-02-03
HRX Arthroscope Orthopedic Class 2 888.1100 2008-02-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2017-04-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-04-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-02-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2011-10-31
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-07-28
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2012-11-28
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2019-05-16
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2019-05-16
HWN Instrument, Compression Orthopedic Class 1 888.4540 1992-12-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-29
PNJ Leadless Pacemaker Cardiovascular Class 3 870.3610 2016-04-07
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2016-04-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2015-03-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-09-24
PGM Growing Rod System Orthopedic Class 2 888.3070 2015-12-08
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-04-13
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-04-13
HXG Tamp Orthopedic Class 1 888.4540 2010-11-18
HRX Arthroscope Orthopedic Class 2 888.1100 2010-11-18
NVZ Pulse Generator, Permanent, Implantable Unknown Class 3 N/A 2002-11-22
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown Class 3 N/A 2002-11-22
KRG Programmer, Pacemaker Cardiovascular Class 3 870.3700 2002-11-22
LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown Class 3 N/A 2002-11-22
OSR Pacemaker/Icd/Crt Non-Implanted Components Unknown Class 3 N/A 2002-11-22
NKE Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) Unknown Class 3 N/A 2002-11-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-08-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-05-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-05-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-05-06
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2014-05-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-05-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-05-06
HWB Extractor Orthopedic Class 1 888.4540 2005-05-31
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 1994-11-09
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-02-02
HXB Probe Orthopedic Class 1 888.4540 2006-06-29
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-10-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-10-12
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-10-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-10-12
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2012-10-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-10-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-01-30
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2020-01-30
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2012-06-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-04-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-04-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-04-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2016-04-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-04-06
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2016-04-06
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2016-04-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-12-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-12-11
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-12-11
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-01-31
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-07-17
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-30
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-30
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2008-02-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-29
HTX Rongeur Orthopedic Class 1 888.4540 2005-05-31
LRP Tray, Surgical General, Plastic Surgery Class 1 878.4800 2020-09-09
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2008-06-05
HXD Clamp General, Plastic Surgery Class 1 878.4800 2005-05-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-26
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-01-26
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-01-26
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-01-26
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-01-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-02-08
LRN Wire, Surgical Orthopedic Class 2 888.3030 2008-02-05
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2005-03-23
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2011-03-03
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2017-06-02
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2012-04-26
HWJ Awl Orthopedic Class 1 888.4540 2002-11-19
HRX Arthroscope Orthopedic Class 2 888.1100 2012-03-21
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
HXW Bender Orthopedic Class 1 888.4540 1992-12-12
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2007-03-08
HTD Forceps General, Plastic Surgery Class 1 878.4800 2006-06-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2011-10-31
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-01-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-10-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-11-14
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-11-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-11-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-11-14
HWA Impactor Orthopedic Class 1 888.4540 2002-11-19
GXD Generator, Lesion, Radiofrequency Neurology Class 2 882.4400 2019-02-26
GXI Probe, Radiofrequency Lesion Neurology Class 2 882.4725 2019-02-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-02-17
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-02-17
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-02-17
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-02-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-02-17
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2017-02-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2011-12-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2011-08-10
HTW Bit, Drill Orthopedic Class 1 888.4540 2006-06-29
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2018-03-01
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-11-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-04-01
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-04-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-04-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2015-04-01
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2015-04-01
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-04-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-04-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-04-01
HXG Tamp Orthopedic Class 1 888.4540 2004-08-18
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-01-13
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2017-11-30
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2009-12-30
HXC Wrench Orthopedic Class 1 888.4540 1992-12-12
FMH Container, Specimen, Sterile Pathology Class 1 864.3250 2003-12-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-08-27
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-04-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-04-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-04-10
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-04-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-04-10
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-04-10
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 1994-11-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2011-01-06
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2011-01-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2011-01-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2011-01-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2011-01-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2011-01-06
KDG Chisel (Osteotome) General, Plastic Surgery Class 1 878.4820 2005-05-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-06-19
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2023-06-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-06-19
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-06-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-06-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-12-17
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2014-09-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-02-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-02-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-02-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-01-05
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2019-09-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-04-04
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2018-04-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-04-04
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2018-04-04
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-04-04
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2018-04-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-02-05
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1994-11-09
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2022-02-23
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-02-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-02-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2022-02-23
HTQ Broach Orthopedic Class 1 888.4540 2011-03-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-08-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-01-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2019-01-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-01-03
HWT Template Orthopedic Class 1 888.4800 2006-05-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-02
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2013-04-10
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2022-07-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-06-26
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-06-26
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-06-26
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2015-06-26
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-06-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-06-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-06-26
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-05-15
NEK Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction Unknown Class 3 N/A 2008-03-31
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2006-06-29
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 1992-12-12
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-10-26
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2016-10-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2016-10-17
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2016-10-17
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2012-05-10
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2012-05-10
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2012-05-10

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
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Other Registrations for Same Entity

Registration Number Establishment Name Location
3007042319 HeartWare, Inc. Miami Lakes, FL, US
3004497303 MEDTRONIC MEXICO EG EMPALME Sonora, MX
3015192387 CATHWORKS Newport Beach, CA, US
3004185781 Medtronic, Inc. Tempe, AZ, US
3012520654 MEDTRONIC, INC. Billerica, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K103464 Medtronic, Inc. PACIFIC XTREME PTCA BALLOON DILATATION CATHETER 2010-12-22
K111339 Medtronic, Inc. HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) 2011-06-08
K032752 R&B Surgical Solutions, LLC R&B SURGICAL SMARTPLATE CERVICAL PLATE SYSTEM 2003-12-03
K062643 Life Spine KINETIC ANTERIOR CERVICAL PLATE 2006-11-16
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0008-2008 Lemaitre Vascular, Inc. 2
CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05 Medrad Inc 2
Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.

Similar Registrations

Registration Number Establishment Name Location
3013186738 Heraeus Medical LLC Yardley, PA, US
3033536319 MEDI.PLAN GMBH & CO. KG Dortmund North Rhine-Westphalia, DE
3004142400 GLOBUS MEDICAL, INC. AUDUBON, PA, US
1649518 Sterigenics US LLC Fort Worth, TX, US
3009170227 INDUSBELLO INDUSTRIA DE INSTRUMENTOS ODO Londrina Parana, BR
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003120897. Last updated year: 2026. Please use registration number 3003120897 when referencing this establishment in official correspondence.
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