FDA Registration
Active
🇺🇸 United States
MEDTRONIC SOFAMOR DANEK USA, INC.
Reg #: 3003120897
·
FEI: 3003120897
·
Expires 2026
Products
122
Proprietary Names
520
Establishment Types
5
Classifications
122
Registration Details
- Registration Name
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Registration Number
- 3003120897
- FEI Number
- 3003120897
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4340 Swinnea Road
- City
- Memphis
- State
- TN
- ZIP
- 38118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020333
- PMA Number
- P000054
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2008-02-25 |
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2021-08-02 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-11-05 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-11-05 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-11-05 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-02-19 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-02-19 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2024-11-14 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2024-11-14 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-02-29 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2021-09-09 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2008-01-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2008-01-31 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-02-18 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2003-05-08 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 1992-12-12 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2020-02-07 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2020-02-07 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2021-08-02 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2014-07-24 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2016-02-10 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction | MPW | Class 3 | Unknown | No | 2008-03-28 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2006-06-29 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2013-02-28 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-02-28 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2013-02-28 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2008-01-31 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2021-01-26 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2021-01-26 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2010-02-22 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2008-02-04 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2008-02-04 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2008-02-04 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2005-05-31 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2008-03-31 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2005-05-31 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | Class 3 | Unknown | No | 2007-12-06 |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | Class 3 | Unknown | No | 2007-12-06 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2006-06-29 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2010-11-19 |
| Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | QON | Class 3 | Gastroenterology, Urology | No | 2011-04-21 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1992-12-12 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2021-12-15 |
| Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | NVN | Class 3 | Unknown | No | 2007-01-24 |
| Pulse Generator, Permanent, Implantable | NVZ | Class 3 | Unknown | No | 2007-01-24 |
| Implantable Cardioverter Defibrillator (Non-Crt) | LWS | Class 3 | Unknown | No | 2007-01-24 |
| Implantable Pulse Generator, Pacemaker (Non-Crt) | LWP | Class 3 | Unknown | No | 2007-01-24 |
| Implantable Pacemaker Pulse-Generator | DXY | Class 3 | Cardiovascular | No | 2007-01-24 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2005-05-31 |
| Permanent Defibrillator Electrodes | NVY | Class 3 | Unknown | No | 2008-03-12 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2013-11-07 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2002-11-19 |
| Stimulator, Thalamic, Epilepsy, Implanted | MBX | Class 3 | Unknown | No | 2006-01-18 |
| Stimulator, Electrical, Implanted, For Parkinsonian Tremor | MHY | Class 3 | Unknown | No | 2006-01-18 |
| Stimulator, Electrical, Implanted, For Parkinsonian Symptoms | NHL | Class 3 | Unknown | No | 2006-01-18 |
| Stimulator, Electrical, Implanted, For Essential Tremor | PJS | Class 3 | Unknown | No | 2006-01-18 |
| Deep Brain Stimulation For The Treatment Of Dystonia | SGS | Class 3 | Unknown | No | 2006-01-18 |
| Motor, Drill, Pneumatic | HBB | Class 2 | Neurology | No | 2010-11-19 |
| Motor, Surgical Instrument, Pneumatic Powered | GET | Class 1 | General, Plastic Surgery | No | 2010-11-19 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2010-11-18 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2008-02-05 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2019-05-16 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 1992-12-12 |
| Leadless Pacemaker | PNJ | Class 3 | Cardiovascular | No | 2016-04-07 |
| Pacemaker/Icd/Crt Non-Implanted Components | OSR | Class 3 | Unknown | No | 2016-04-07 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2010-11-18 |
| Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) | NIK | Class 3 | Unknown | No | 2002-11-22 |
| Programmer, Pacemaker | KRG | Class 3 | Cardiovascular | No | 2002-11-22 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | NKE | Class 3 | Unknown | No | 2002-11-22 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2005-05-31 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Probe | HXB | Class 1 | Orthopedic | No | 2006-06-29 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-02-01 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2005-05-31 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2020-09-09 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2008-02-05 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2017-06-02 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2002-11-19 |
| Bender | HXW | Class 1 | Orthopedic | No | 1992-12-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2006-06-29 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2002-11-19 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2019-02-26 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2019-02-26 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2006-06-29 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2009-12-30 |
| Wrench | HXC | Class 1 | Orthopedic | No | 1992-12-12 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2003-12-15 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2011-03-11 |
| Template | HWT | Class 1 | Orthopedic | No | 2006-05-17 |
| Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction | NEK | Class 3 | Unknown | No | 2008-03-31 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 1992-12-12 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2016-10-17 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2006-06-29 |
| Bone Grafting Material, Dental, With Biologic Component | NPZ | Class 3 | Dental | No | 2008-03-31 |
| Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence | QPT | Class 3 | Unknown | No | 2025-09-19 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 1978-02-15 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2019-05-21 |
| Pump, Infusion, Implanted, Programmable | LKK | Class 3 | Unknown | No | 2006-04-21 |
| Stimulator, Electrical, Implantable, For Incontinence | EZW | Class 3 | Gastroenterology, Urology | No | 2007-12-26 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2008-01-17 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2008-02-27 |
| Tape, Orthopedic | HXT | Class 1 | General, Plastic Surgery | No | 2021-04-15 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 1978-02-15 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Corkscrew | HWI | Class 1 | Orthopedic | No | 2008-12-12 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2001-03-30 |
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2008-02-12 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2001-03-30 |
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
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
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
Catalyft PL Expandable Interbody System
CD Spire Spikes
Medtronic Reusable Instrument
MAST QUADRANT Retractor System
Medtronic Transportation_Sterilization Cassettes
SHILLA Growth Guidance 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
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
Rasp
Clydesdale Spinal System
SOVEREIGN 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
InterStim iCon 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 Modular 5.5/6mm Spinal System
ORION Anterior Cervical
ANTERIOR CERVICAL PLATE SYSTEM
Verte-Stack Crescent
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
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
MULTIPLE (SCISSORS)
Anatomic Peek PTC Cervical Fusion System Cage
Expandable Cage
Wave O 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
NIM Eclipse
PIVOX" Oblique Lateral Spinal System
ZPlate II
Activa Tremor Control Therapy
Access Therapy Controller
Activa RC Neurostimulator
Activa PC Neurostimulator
StimLoc
Activa SC Neurostimulator
DBS Extension Kit
Access Review Therapy Controller
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
METRx Endoscope
Navigated Elevate Spinal System
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
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 Solera 5.5/6 Sagittal Adjusting Screws
Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
TSRH
CD Perc Trauma
CAPSTONE-L SPINAL SYSTEM
Pyramid +4 Anterior Lumbar Plate
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)
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
Kyphon Express Inflatable Bone Tamp
Inflate FX Fracture Management Inflatable Bone Tamp
Kyphon Exact Inflatable Bone Tamp
Verte-Stack Perimeter XS
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
Accurian
Vantage Plates
Capstone Spinal System
MULTIPLE TWIST
Drill; Introducer Tool
BIT DRILLS
DRILL BIT (ORTHOPEDIC MA
MEROCEL SPONGE
Medtronic Dissector Tool
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
MULTIPLE (CHISELS
OSTEOTOMES)
CLYDESDALE Spinal System
PRESTIGE LP Cervical Disc System
TSRH Expanded Pedicle Screw
Pyramid Non-constrained Cover Plate
T2 STRATSOPHERE Expandable Corpectomy System
Danek Unit Rod
BONE HOOK
Catalyft PL Expandable Interbody System
ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
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
RIALTO SI Fusion System
POWEREASE
MULTIPLE (ORTHOPEDIC OSTEOTOMES)
ENT)
ORTHOPEDIC MANUAL SURGICAL INSTRUM
INFUSE BONGRAFT for Oral Max
Altaviva Patient Programmer Kit
Altaviva Neurostimulator
Patient Programmer
Altaviva Clinician Kit
Wireless Recharger
Altaviva Clinician Programmer Kit
Recharging Dock
Ankle Band
CD HORIZON VOYAGER"
Verte-Span Lift VB
Fuse Spinal System/ PLIF Titanium Cage
BONE TAP
Endoskeleton TCS Interbody Fusion Device
Wave D- Spinal System
Anatomic Peek
Marksman
Aquamantys SBS 5 Sheathed Bipolar Sealer (23-312-1)
Aquamantys Mini EVS 3.4 Epidural Vein Sealer (23-314-1)
Aquamantys Epidural Vein Sealer (23-121-1)
Aquamantys 2.3 Bipolar Sealer (23-113-1);
SynchroMed Infusion Pump System
SynchroMed II Infusion Pump System
myPTM Personal Therapy Manager
Ascenda Catheter
Indura 1P Catheter
SynchroMed® II Clinician Programmer
PumpSynchroMed Clinician Programmer
SynchroMed III
Osteocool" Connector Hub
OsteoCool" Independent Thermocouple
OsteoCool" RF Ablation Probe Kit
OsteoCool" Pump and Pump Cable
OsteoCool" Desk Stand
OsteoCool" Cart Stand
OsteoCool" RF Ablation System Generator
Sextant Percutaneous
SOVEREIGN SPINAL SYSTEM
InterStim Neurostimulator
InterStim Sacral Nerve Stimulation
InterStim iCon Patient Programmer
InterStim II Sacral Nerve Stim
METRx Microscope
CareLink Network Software
Protecta VR
Marquis VR ICD
Visia AF MRI VR SureScan
Evera XT VR
Protecta DR
Visia AF MRI S VR SureScan
Virtuoso II DR/VR ICD
Maximo II DR
Visia AF VR
Evera MRI S VR
Evera XT DR
Evera MRI XT DR SureScan
Maximo VR ICD
Evera S DR
Evera MRI S DR SureScan
Marquis DR ICD
Evera S VR
Secura DR
Protecta XT VR
Protecta XT DR
Intrinsic ICD
Evera MRI XT VR SureScan
EnTrust ICD
Secura VR
Evera
Medtronic Longevity
Maximo II VR
Maximo DR ICD
Primo MRI VR SureScan
Primo MRI DR SureScan
Cobalt XT DR MRI Surescan
Cobalt VR MRI Surescan
Cobalt DR MRI Surescan
Crome DR MRI Surescan
Crome VR MRI Surescan
Cobalt XT VR MRI Surescan
CD Horizon Spinal System ; CD Horizon Mazor Modulex Spinal System
NIM SPINE SYSTEM
NIM
KYPHON Cement Delivery System
KyphX Bone Filler Device
CareLink SmartSyncTM Aurora EV-ICDTM Application D00U025
Epsila EV MRI SureScan extravascular lead
Aurora EV-ICD MRI SureScan extravascular implantable cardioverter defibrillator
Epsila EV Sternal Tunneling Tool
AURORA EV-ICD MRI SURESCAN SW041
Epsila EV Transverse Tunneling Tool
Verte-Stack Telamon Ti
RONGEUR
CD Horizon Ballast" Spinal System
Verte-Stack Perimeter Peek
RETRACTOR
RadiaLux
Spacekeeper
EEA TAID
Guide Pin; Introducer Tool
DRILL GUIDES
GUIDE WIRES (PINS)
LAA Selection Guide
Cannula; Introducer tool
Verte-Stack Clydesdale
, MOTORS
DRILLS
SURGICAL DRIVE SYSTEM
CORKSCREW
VERTE-STACK(TM)SPINAL SYSTEM
Liberty Spinal System
CD LIBERTY POSTERIOR SPINCAL SYSTEM
Disposable Pouch
Patient Cable
Disposable EPG Cover
Capstone Control
CD HORIZON Spinal System
Anteralign Spinal System with Titan nanolOCk
Atlantis Vision Anterior Cervical
CORNERSTONE PSR Cervical Fusion System
Endoskeleton® TAS Interbody Fusion Device
Endoskeleton® TAS Hyperlordotic Interbody Fusion Device And Endoskeleton® TCS Interbody Fusion Device
CAPSTONE PTC SPINAL SYSTEM
Verte-Stack Capstone L
Tray, Surgical, Instrument
instrument tray
Aspen
Bard-Parker
Wire Nest
ELEVATE" Spinal System
CEMENT
VERTEBROPLASTY
X-STOP® Interspinous Spacer Titanium
POWEREASE System
Bipolar forcep
PERIMETER Interbody Fusion Device
Multiple High Speed systems
BONE MILL
Endoskeleton TCS System
DIVERGENCE-L" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
HourGlass Vertebral Body Spacer
Kyphon Inflation Syringe
Analyzer Adapter
Prodigy IPG
Medtronic CareLink Monitor
Service Kit
Adapter Cable
Sterile Plastic Sleeve
CapSure Lead
CareLink Express Mobile System - Android
CapSure VDD-2 Lead
CareLink Express Monitor
ECG Port Plug
ECG Output Adapter
CareLink Wireless Network Adapter Card
Program Interface Cable
CareLink Express Mobile System - iOS
CareLink Encore Programmer
Analyzer Cable
ECG Cable
Lead Analyzer
MyCareLink Patient Monitor
CardioSight Reader
CareLink Encore Programmer RF Head
CareLink Programmer RF Head
Medtronic CareLink Programmer
CareLink SmartSync Power Cord 249705
CareLink SmartSync Patient Connector 24967
CareLink SmartSync Base 24970A
CareLink SmartSync PSA Application
CareLink SmartSync Common Application iOS
CareLink SmartSync Power Supply 249701
Integrated Diagnostics Data Calculation Module Model 5242
Instrument Command Library (ICL)Device Command Library (DCL)
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only
Develop Specifications But Do Not Manufacture At This Facility
Remanufacture Medical Device