Medtronic Medical Costa Rica S.R.L.

FDA Device Registration & Listing · Coyol Alajuela, CR · Registration 3014725904

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
3014725904
FEI Number
3014725904
Entity Name
Medtronic Medical Costa Rica S.R.L.
City/State/Country
Coyol Alajuela, CR
Establishment Address
Coyol Free Zone Bldg B7, Multitenant 7-8, Module F, Coyol Alajuela 20113, CR
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
K173338
PMA Number
N/A

All Registered Proprietary Names

CD HORIZON® Fenestrated Screw Set RIALTO™ SI Fusion System Vertex Keel Plate CD HORIZON ESSENTIALS™ Spinal System CD HORIZON ESSENCE TSRH Spinal system Crosslink Plates Spinal System TSRH CD Horizon Advanta Spinal System Spinal System CD Spinal System MSB PYRAMESH® Implant System CD Horizon 3.5 Rods ZEVO Anterior Cervical Plate System CD Horizon-Spinal System/ CD Horizon SOLERA CD HORIZON Spinal System SPINE PLATE LAMINOPLASTY CD Horizon Spinous Plate CD HORIZON® Spinal System CD Cannulated Screw DIVERGENCE-L" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM CD Horizan Spinal Ti Spinal System Vantage Bolts TSRH Chromaloy Plus Precut Contoured Rods TSRH Osteogrip CD 4.5 Crosslink Plates Pyramid +4 Anterior Lumbar Plate CD HORIZON® Spinal System VERTEX® Reconstruction System VERTEX® Reconstruction System TENOR Spinal System MODIFICATION TO TENOR SPINAL SYSTEM-PLATES CD Horizon Spinal System CRESCENT™ SPINAL SYSTEM TITANIUM ELEVATE™ SPINAL SYSTEM CRESCENT™ SPINAL SYSTEM CAPSTONE PTC™ SPINAL SYSTEM TSRH TC 3D MPA Screw CD Horizan M8 Screws Vantage Plates Vertex Reconstruction System CD HORIZON(R) Spinal System CD Spire Spikes Catalyft™ PL Expandable Interbody System TSRH Spinal System TSRH Expanded Pedicle Screw Vertex Lateral Connectors Vertex Reconstruction System TSRH TC Splined Connectors & Screws CD HORIZON Spinal System Atlas Cable Pyramesh CD HORIZON® Fenestrated Screw Set KYPHON Cement Delivery System KyphX Bone Filler Device CD Horizon Spinal System Pyramesh TSRH Cobalt Chrome Rods CD HorizonSpinal System CD Perc Trauma Vertex Reconstruction System CD Staples and Screws Vertex Crosslinks MULTIPLE TWIST Drill; Introducer Tool MICRO-FRANCE BIT DRILLS DRILL BIT (ORTHOPEDIC MA ARTHROSCOPE ELEVATE" Spinal System CD Horizon Legacy 4.5 PYRAMID +4 Anterior Lumbar Plate S METRx Endoscope CD HORIZON Spinal System SDS Pre-Bent Rods TSRH Spinal System General Instrument PASS LP Spinal System ZPlate II Townley Transfacetpedicular Screw Pyramesh Implant System NAVIGATED INFINITY™ Instruments CD HORIZON Growth Rod Conversion Set Spinal System Spinal System CD HORIZON SOLERA Spinal System TSRH Spinal System Prebent/precut r Atlantis Translational Plate SOVEREIGN Spinal System VERTEX® Reconstruction System CD HORIZON® Spinal System Vertex Reconstruction System CD HORIZON Solera 5.5/6 CD HORIZON® SOLERA® Spinal System Tenor Spinal System CD Horizon Set Screws CD Horizan Eclipse M8 Screws TEMPLATE Vertex Reconstruction System VERTEX Spinal System CD HORIZON Fenestrated Screw Set Kyphon HV-R Fenestrated Screw Cement Vertex Adjustable Plate TSRH Hook Holder CD HORIZON® SOLERA® Spinal System CD HORIZON Spinal System SOLERA Atlantis Vision Anterior Cervical CD Horizon Eclipse CD HORIZON® Spinal System CD Horizon Spinal System MAST QUADRANT™ Retractor System Pyramesh C Vertex Max Vertex Occipital Components CCD Spine System CD Horizon M8 M10 Reduction Hooks TSRH Spinal System TSRH 3Dx 90 Degree Offset Connector INFINITY™ OCT System Spinal System Multi Axial Screw System CD Horizon- Spinal System VERTEX Reconstruction System CD HORIZON Spinal System PIVOX" Oblique Lateral Spinal System Vertex OC MAS, Rods, Hooks CD 5.5mm Set Screws CD HORIZON Spinal System Vertex Reconstruction Occipital CD Horizon MAS Design Enhancement CD HORIZON Spinal System CDH Solera 4.75 CD HORIZON SOLERA" Orfil Spine Fixation system Vertex Reconstruction System NAVIGATED INFINITY™ Instruments

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-10-06
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2020-10-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-10-06
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2020-10-06
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-10-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-10-06
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2020-10-06
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
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-30
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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-02-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-02-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-02-14
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-14
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2023-06-23
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
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
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
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2023-07-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2023-06-23
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
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2022-11-03
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-31
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-02-12
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-07-01
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-07-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-07-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-07-01
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-07-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-07-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-07-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-07-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-07-18
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2012-07-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-07-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-07-18
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2007-03-08
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
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
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
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
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2015-06-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-06-23
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-06-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2011-01-07
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2011-01-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2011-01-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2011-01-07
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2011-01-07
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-09-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-09-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2009-09-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-09-01
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-09-01
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
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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-01
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2020-03-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-03-31
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-28
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
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2011-01-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2011-01-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2011-01-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2011-01-06
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2017-12-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-02-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-02-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-02-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-02-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 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 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-29
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
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
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-02-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-02-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-02-13
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-02-13
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-26
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-02-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2008-02-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2008-02-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-02-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-05-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-05-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-05-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-05-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2009-05-27
LRN Wire, Surgical Orthopedic Class 2 888.3030 2008-02-05
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2023-07-27
KIH Dispenser, Cement Orthopedic Class 1 888.4200 2008-02-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-30
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-30
EZX Mesh, Surgical, Metal General, Plastic Surgery Class 2 878.3300 2023-07-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 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
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
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
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-09-04
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
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
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-30
HTW Bit, Drill Orthopedic Class 1 888.4540 2006-06-29
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2005-03-23
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2015-08-19
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-05-08
HRX Arthroscope Orthopedic Class 2 888.1100 2008-02-05
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2014-11-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2014-11-05
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2014-11-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2014-11-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2014-11-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2014-11-05
NKB Thoracolumbosacral Pedicle Screw System 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 2008-12-11
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-12-11
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2006-06-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-30
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2008-02-04
EZX Mesh, Surgical, Metal General, Plastic Surgery Class 2 878.3300 2008-02-01
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-05-23
PGM Growing Rod System Orthopedic Class 2 888.3070 2015-12-08
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2023-07-17
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-06-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2020-09-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-09-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-09-16
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-29
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2009-11-19
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-12-30
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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-02-12
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-31
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2008-01-31
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
NKB Thoracolumbosacral Pedicle Screw System 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
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
HWT Template Orthopedic Class 1 888.4800 2006-05-17
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-29
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-05-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-06-23
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 2009-08-25
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-29
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
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2009-11-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2009-11-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2009-11-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2009-11-03
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2009-11-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-11-03
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2008-01-29
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
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
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-31
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
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2008-02-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-02-12
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
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
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
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2011-03-03
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2011-03-03
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2011-03-03
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2011-03-03
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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2023-06-23
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-02-01
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2013-05-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2013-05-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-05-06
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-05-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-05-06
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-05-06
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2009-02-05
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
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
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
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2008-01-30
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
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
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
NQP Posterior Metal/Polymer Spinal System, Fusion Orthopedic Class 2 888.3070 2015-09-18
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2015-09-18
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2015-09-18
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-09-18
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2015-09-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2015-09-18
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-30
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
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2012-01-05
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2012-01-05
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2012-01-05
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2012-01-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2012-01-05
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2012-01-05
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-02-04
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2008-01-29
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2018-02-16

Official Correspondent

No official correspondent registered.

US Agent Details

Michelle Obenauer Business: MEDTRONIC INC. Email: michelle.obenauer@medtronic.com Phone: (901) 3992117

Related Public Records

Same Entity

Medtronic, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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
K163363 Surgtech, Inc. SurgTech Thoracolumbosacral (TLS) Posterior Fixation System 2017-04-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014725904. Last updated year: 2026. Please use registration number 3014725904 when referencing this establishment in official correspondence.
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