ORTHOFIX US LLC

FDA Device Registration & Listing · Lewisville, TX, US · Registration 2183449

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
2183449
FEI Number
2183449
Entity Name
ORTHOFIX US LLC
City/State/Country
Lewisville, TX, US
Establishment Address
3451 Plano Parkway, Lewisville, TX 75056, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Orthofix US LLC (Owner Number: 10028162)
Owner / Operator Contact Address
3451 Plano Parkway, Lewisville, TX 75056, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K050892
PMA Number
N/A

All Registered Proprietary Names

MIOT plating system TIBIAL NAILING SYSTEM BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallma Class I instrument BLACKSTONE ASCENT POCT SYSTEM 5.5MM/3MM SINGLE AXIAL CONNECTOR Class I instrument Electro-Biology HALLMARK ANTERIOR CERVCIAL PLATE SYSTEM, HALLMARK FIVE-LEVEL CERVICAL PLATES plate bone pediatric CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer Class I instrument Class I instrument CONTOURS Proximal humeral plate ORTHOFIX ACP (ANTERIOR CERVICAL PLATE SYSTEM) FIREBIRD SI Fusion System UNITY LX ANTEROLATERAL LUMBAR PLATE FIXATION SYSTEM BLACKSTONE SPINAL FIXATION SYSTEM CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System Class I instrument Connector System M6-C Artificial Cervical Disc Instruments AS Class I instrument Agile Nail Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Pho Class I instrument Class I instrument Navigated Instrument System Class I instrument Class I instrument FIREBIRD SPINAL FIXATION SYSTEM CONTOURS LAPIDUS PLATING SYSTEM Class I instrument Class I instrument Class I instrument Class I instrument TrueLok Hexapod System (TL-HEX) V2 BLACKSTONE CLASSIC ANTERIOR CERVICAL PLATE BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR Class I instrument FIREBIRD SPINAL FIXATION SYSTEM, FIREBIRD SIDE-LOADING BODY JPS JuniOrtho Plating System Class I instrument JuniOrtho Plating System SKYHAWK LATERAL PLATE SYSTEM BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM Azure Anterior Cervical Plate System Class I instrument TrueLok Evo KAWE stethoscope EXTERNAL FIXATION SCREW (PIN) WITH HYDROXYAPATITE COATING Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spina Class I instrument GUIDED GROWTH SYSTEM EIGHT-PLATE, QUAD-PLATE (STAINLESS STEEL Class I instrument FitboneTM Trochanteric BLACKSTONE POSTERIOR CERVICAL SYSTEM Atlas Spine Expandable Interbody System ASCENT POSTERIOR OCCIPITAL THORACIC (POCT) SYSTEM (TITANIUM & COBALT CHROME RODS) BLACKSTONE SURGICAL TITANIUM MESH Class I instrument BLACKSTONE MEDICAL, INC. LAPAROSCOPIC DISC REMOVAL SYSTEM BLACKSTONE SFS PARALLEL ROD CONNECTORS Connector System FEMORAL NAILING SYTEM Class I instrument AZURE ANTERIOR CERVICAL PLATE SYSTEM CONSTRUX Mini PEEK Spacer System, CONSTRUX Mini PEEK Ti Spacer System Class I instrument BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM IPY Centurion POCT System BLACKSTONE ASCENT MULTIAXIAL SCREWS CONSTRUX MINI PEEK; SPACER SYSTEM, TI SPACER SYSTEM, CERVICAL STAND ALONE SYSTEM SAMBA SCREW, 9MM DIA., 25MM LONG, SAMBIA SCREW, 9MM DIA., 30MM LONG, SAMBA SCREW 9MM DIA., 35MM LONG, SAMBA SCREW, 9MM D CETRA Anterior Cervical Plate System ICON (TM) MODULAR PEDICLE SCREW SYSTEM FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion System CONSTRUX PL/TL PEEK PARTIAL VBR SYSTEM FIREBIRD SPINAL FIXATION SYSTEM Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Def ORTHOFIX VOLAR DISTAL RADIAL PLATE MJ-FLEX THE NEW METAIZEAU NAIL Accelstim Class I instrument Class I instrument BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS ORTHOFIX MODULSYSTEM FITBONE(R) TAA CONTOURS VSP III VOLAR PLATING SYSTEM REDUCE FRACTURE PLATING SYSTEM BLACKSTONE SPINAL FIXATION SYSTEM SPACER GROWTH GUIDANCE PLATE TrueLok Elevate Firebird SI Navigation System Cervical Stand Alone System PILLAR SA Ti Spacer System BLACKSTONE III ANTERIOR CERVICAL PLATING SYSTEM (PLATE WASHER) FIREBIRD SI Fusion System FORZA XP Expandable Spacer System CENTURION POCT SYSTEM SambaScrew 3D SI Fusion System CHIMAERA Hip Fracture System - Trochanteric Nailing System Class I instrument BLACKSTONE MEDICAL, INC., PILLAR SPACER SYSTEM Class I instrument Physiostim and Spinalstim Class I instrument Class I instrument FORZA Ti Spacer System Class I instrument CERVICAL STAND ALONE SYSTEM BLACKSTONE PILLAR XL PEEK SPACERS BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MONO-AXIAL SCREW Class I instrument Class I instrument Class I instrument BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE FIREBIRD SI Fusion System Class I instrument Class I instrument Centurion POCT System GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM FIREBIRD SPINAL FIXATION SYSTEM, PHOENIX MIS SPINAL FIXATION SYSTEM BLACKSTONE PEDICLE SCREW SYSTEM Guided Growth Plate System Plus FORZA® XP Expandable Spacer System Class I instrument Class I instrument plate fixation bone Titanium Nailing System BLACKSTONE SPINAL FIXATION SYSTEM 4.5MM MULTI-AXIAL SCREW G-Beam Fusion Beaming System ankle hindfoot nailing system Class I instrument BIOTRONIK torque wrench Class I instrument Class I instrument O-Genesis Graft Delivery System FITBONE® Transport and Lengthening System BLACKSTONE SPINAL FIXATION SYSTEM, SECOND-GENERATION CROSS-CONNECTOR FORZA PTC Spacer System MODIFICATION TO ISKD (INTRAMEDULLARY SKELETAL KINETIC DISTRACTOR RIVAL View Plating Systems and Reduce Fracture Plating Systems Class I instrument Guided Growth Plate System Plus Oscar 3 Cervicalstim BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System FIREBIRD SPINAL FIXATION SYSTEM BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM FIREBIRD SI Fusion System BLAKSTONE LAMINOPLASTY FIXATION SYSTEM Class I instrument Class I instrument Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System Class I instrument BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM FIREBIRD SPINAL FIXATION SYSTEM additional accessories for Orthofix system FORZA SPACER SYSTEM BLACKSTONE MEDICAL INC. ANTERIOR CERVICAL PLATE SYSTEM Class I instrument Class I instrument BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER Class I instrument Class I instrument Class I instrument Galaxy UNYCO System Connector System Class I instrument Class I instrument SKYHAWK INTERBODY FUSION SYSTEM Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System CONSTRUX Mini Ti Spacer System HALLMARKTM ANTERIOR CERVICAL PLATE SYSTEM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2022-03-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-03-16
HRR Scissors, Orthopedic, Surgical Orthopedic Class 1 888.4540 2015-11-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
HWT Template Orthopedic Class 1 888.4800 2009-08-31
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2009-01-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2010-07-08
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2016-01-11
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-11-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-09-07
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2021-09-07
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-09-07
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-09-07
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-09-07
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 2015-09-24
GDI Dissector, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-08-31
KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Orthopedic Class 2 888.3030 2025-11-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-06-06
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2020-04-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-08-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-08-31
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2020-08-05
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2020-08-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-08-05
HXD Clamp General, Plastic Surgery Class 1 878.4800 2015-09-24
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-05-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-05-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-05-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-05-19
QLQ Manual Instruments Designed For Use With Total Disc Replacement Devices Orthopedic Class 2 888.4515 2025-11-20
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2009-08-31
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2018-10-11
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2015-09-24
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2009-08-31
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-05-16
HXE Fork Orthopedic Class 1 888.4540 2015-11-09
HTQ Broach Orthopedic Class 1 888.4540 2015-11-09
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-04-24
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-04-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-04-24
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2017-04-24
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-04-24
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2011-03-04
HXB Probe Orthopedic Class 1 888.4540 2009-08-31
HXC Wrench Orthopedic Class 1 888.4540 2009-08-31
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2009-08-31
HWQ Passer Orthopedic Class 1 888.4540 2015-11-09
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-11-20
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2025-11-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-08-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
HTT Burr, Orthopedic Orthopedic Class 1 888.4540 2015-11-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2010-07-08
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2010-07-08
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2010-07-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-20
HWR Driver, Prosthesis Orthopedic Class 1 888.4540 2009-08-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-10-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-04-24
HWK Trephine Orthopedic Class 1 888.4540 2015-09-24
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2025-11-20
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-11-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-11-20
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2025-11-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-05-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-05-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-05-19
HWM Osteotome General, Plastic Surgery Class 1 878.4800 2015-09-24
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2011-10-18
HXG Tamp Orthopedic Class 1 888.4540 2009-08-31
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-05-24
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2011-06-18
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2009-08-31
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2009-08-31
HRX Arthroscope Orthopedic Class 2 888.1100 2009-08-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-03-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-03-23
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2020-03-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-03-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-20
HXO Pusher, Socket Orthopedic Class 1 888.4540 2009-08-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-06-06
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-04-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-04-24
GDZ Handle, Scalpel General, Plastic Surgery Class 1 878.4800 2009-08-31
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-11-14
IPY Orthosis, Lumbo-Sacral Physical Medicine Class 1 890.3490 2009-01-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-06-15
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2020-06-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-14
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-04-24
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-04-24
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2017-04-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-10-19
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2016-10-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-04-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-04-24
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2017-04-24
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-11-14
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2017-04-24
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-04-24
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2017-04-24
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2017-04-24
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2021-08-11
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2021-08-11
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2021-08-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-08-11
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-08-11
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2009-01-05
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-20
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2025-11-20
LOF Stimulator, Bone Growth, Non-Invasive Orthopedic Class 2 890.5870 2022-05-09
HWA Impactor Orthopedic Class 1 888.4540 2009-08-31
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2009-08-31
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-11-14
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2009-01-05
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2010-12-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2010-12-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2009-01-05
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-11-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-11-19
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2017-04-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-02-07
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-02-07
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2020-09-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-03-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-10-29
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2020-03-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-20
JOL Catheter And Tip, Suction General Hospital Class 2 880.6740 2009-08-31
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2009-08-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2009-08-31
HTD Forceps General, Plastic Surgery Class 1 878.4800 2015-09-24
LOF Stimulator, Bone Growth, Non-Invasive Orthopedic Class 2 890.5870 2009-01-05
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2009-08-31
HXQ Crimper, Pin Orthopedic Class 1 888.4540 2015-09-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-03-22
HXX Screwdriver Orthopedic Class 1 888.4540 2009-08-31
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2014-04-17
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-11-14
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2012-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-08-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-08-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-08-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-08-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2015-11-09
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2009-08-31
HWX Tap, Bone Orthopedic Class 1 888.4540 2009-08-31
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2012-11-14
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2012-11-14
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2021-03-25
GEA Cannula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-08-31
HTX Rongeur Orthopedic Class 1 888.4540 2009-08-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-04-24
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-04-24
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2025-11-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-12-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-12-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-12-28
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2025-11-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-10-11
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2015-09-24
FZT Cutter, Surgical General, Plastic Surgery Class 1 878.4800 2009-08-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-01-11
JDS Nail, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-20
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-20
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-08-31
GDW Staple, Implantable General, Plastic Surgery Class 2 878.4750 2025-11-20
HWN Instrument, Compression Orthopedic Class 1 888.4540 2015-11-09
HXL Mallet General, Plastic Surgery Class 1 878.4800 2009-08-31
FMF Syringe, Piston General Hospital Class 2 880.5860 2020-08-06
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2025-11-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-08-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-08-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-08-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2016-02-11
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2009-01-05
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-11-20
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-11-20
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2009-08-31
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2025-11-20
LZV System, Cement Removal Extraction Orthopedic Class 2 888.4580 2025-11-20
JDX Instrument, Surgical, Sonic And Accessory/Attachment Orthopedic Class 2 888.4580 2025-11-20
LOF Stimulator, Bone Growth, Non-Invasive Orthopedic Class 2 890.5870 2009-01-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-10-11
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2018-10-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2018-10-11
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-14
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2020-11-18
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2009-08-31
GCZ Retainer, Surgical General, Plastic Surgery Class 1 878.4800 2015-10-12
HTO Reamer Orthopedic Class 1 888.4540 2015-11-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2016-07-14
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2016-07-14
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2016-07-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2016-07-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2016-07-14
HXW Bender Orthopedic Class 1 888.4540 2009-08-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-08-31
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-08-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-11-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-06-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-06-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-06-06
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2009-01-05
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2011-10-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-08-31
GAD Retractor General, Plastic Surgery Class 1 878.4800 2009-08-31
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2015-09-24
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-11-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-11-14
HWB Extractor Orthopedic Class 1 888.4540 2015-11-09
GAH Stylet, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-08-31
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2009-08-31
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2025-11-20
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2017-10-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-10-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2017-10-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-10-09
HTW Bit, Drill Orthopedic Class 1 888.4540 2009-08-31
HTC Pliers, Surgical General, Plastic Surgery Class 1 878.4800 2015-09-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-10-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-10-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-10-19
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2015-10-19
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-10-19
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-10-19
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-03-22
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-11-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Orthofix US LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042598 Zimmer, Inc. PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES 2004-10-29
K190842 Jiangsu Trauhui Medical Instrument Co., Ltd. Comus Locking Plate systems 2020-02-03
K130510 Arthrex, Inc. ARTHREX COMPRESSION PLATES 2013-09-25
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K040336 Synthes (Usa) SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM 2004-04-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0034-2022 Flower Orthopedics Corporation 2
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
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.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.

Similar Registrations

Registration Number Establishment Name Location
3013843055 BEIJING AK MEDICAL CO, LTD Changping District Beijing, CN
3022777867 FIXIER S.A. DE C.V. Doctor Mora Guanajuato, MX
3017209758 NEBULA SURGICAL PRIVATE LIMITED Rajkot Gujarat, IN
3017609305 PRIMEMED INC. Sungnam-city Gyeonggi, KR
3015410662 Jabil Inc. (Wilson Drive) W Chester, PA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2183449. Last updated year: 2026. Please use registration number 2183449 when referencing this establishment in official correspondence.
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