FDA Registration
Active
🇺🇸 United States
MEDTRONIC SOFAMOR DANEK USA, INC.
Reg #: 1030489
·
FEI: 1000477302
·
Expires 2026
Products
118
Proprietary Names
515
Establishment Types
2
Classifications
118
Registration Details
- Registration Name
- MEDTRONIC SOFAMOR DANEK USA, INC.
- Registration Number
- 1030489
- FEI Number
- 1000477302
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1800 PYRAMID PLACE
- City
- Memphis
- State
- TN
- ZIP
- 38132
- Country
- US
Regulatory Submissions
- 510(k) Number
- K001066
- PMA Number
- P050053
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 |
|---|---|---|---|---|---|
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2020-09-09 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2008-01-31 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2008-01-31 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2008-01-31 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2008-01-31 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2008-02-25 |
| Bone Grafting Material, Synthetic | LYC | Class 2 | Dental | No | 2010-11-10 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-03-22 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2016-03-22 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-03-22 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-03-22 |
| Template | HWT | Class 1 | Orthopedic | No | 2006-05-17 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2015-12-14 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2015-12-14 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2008-02-01 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2015-08-07 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2015-08-07 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2008-01-31 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2008-02-04 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2017-12-11 |
| Device, Percutaneous, Biopsy | MJG | Class 1 | General, Plastic Surgery | No | 2008-02-25 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2008-01-31 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 1978-02-15 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2011-10-31 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2014-06-05 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2003-05-08 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2011-04-19 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2011-04-19 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Bone Grafting Material, Dental, With Biologic Component | NPZ | Class 3 | Dental | No | 2008-03-31 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 2003-12-15 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2021-09-09 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-02-01 |
| Prosthesis, Finger, Polymer | KWF | Class 2 | Orthopedic | No | 2008-01-31 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2013-02-28 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2008-02-01 |
| Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | MBP | Class 2 | Orthopedic | No | 2011-11-21 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2016-03-28 |
| Tape, Orthopedic | HXT | Class 1 | General, Plastic Surgery | No | 2021-04-15 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2011-11-22 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2018-12-05 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2011-03-03 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-02-03 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2026-01-12 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2010-02-22 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2008-02-05 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 1992-12-12 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2015-12-08 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2008-03-31 |
| Generator, Lesion, Radiofrequency | GXD | Class 2 | Neurology | No | 2019-02-26 |
| Probe, Radiofrequency Lesion | GXI | Class 2 | Neurology | No | 2019-02-26 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2009-12-16 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2006-06-29 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2002-11-19 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2006-06-29 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2002-11-19 |
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2008-02-12 |
| 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 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2016-10-17 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2005-05-31 |
| Corkscrew | HWI | Class 1 | Orthopedic | No | 2008-12-12 |
| Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar | NVR | Class 3 | Unknown | No | 2007-03-08 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2005-03-23 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2008-02-27 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2024-05-31 |
| Bone Grafting Material, Human Source | NUN | Class 2 | Dental | No | 2011-11-21 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2008-01-31 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2007-03-08 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2008-02-01 |
| Broach | HTQ | Class 1 | Orthopedic | No | 2011-03-11 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2006-06-29 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction | NEK | Class 3 | Unknown | No | 2008-03-31 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2005-03-23 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2002-11-19 |
| Electrode, Needle | GXZ | Class 2 | Neurology | No | 2016-08-23 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 1992-07-20 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2005-05-31 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2005-05-31 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2005-05-31 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2001-03-30 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1992-12-12 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2016-02-10 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2008-01-25 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 1992-12-12 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Probe | HXB | Class 1 | Orthopedic | No | 2006-06-29 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2008-02-05 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2006-06-29 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 1992-12-12 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2001-03-30 |
| Cable | ISN | Class 1 | Physical Medicine | No | 1992-12-12 |
| Guide, Needle, Surgical | GDF | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 1978-02-15 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2008-01-31 |
| Wrench | HXC | Class 1 | Orthopedic | No | 1992-12-12 |
| Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction | MPW | Class 3 | Unknown | No | 2008-03-28 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Bender | HXW | Class 1 | Orthopedic | No | 1992-12-12 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2005-05-31 |
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2015-04-24 |
| Implant, Fixation Device, Spinal | JDN | Class 2 | Orthopedic | No | 2008-01-30 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2006-06-29 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2008-01-17 |
Proprietary Names
TRAY, SURGICAL
CD Horizon Eclipse
CD HORIZON® Spinal System
Kyphon Mixer
Mastergraft Mini Granules
XANTUS Anterior Lateral
VERTEX
CD Horizon Ballast" Spinal System
TEMPLATE
Endoskeleton(R) TCS System
TSRH Spinal System MPA Screws
Verte-Stack Capstone L
KYPHON ELEMENT" Inflatable Bone Tamp
CD Modified Sextant II Instruments
UCSS Non-Cannulated
Vertex Reconstruction System
CRESCENT SPINAL SYSTEM TITANIUM
ELEVATE SPINAL SYSTEM
CRESCENT SPINAL SYSTEM
CAPSTONE PTC SPINAL SYSTEM
KyphX Bone Biopsy Device
TSRH
Townley Transfacetpedicular Screw
Atlantis Vision Anterior Cervical
CLYDESDALE Spinal System
CD Horizon 3.5 Rods
Threaded Cement Restrictor Ti
Catalyft PL Expandable Interbody System
spinal system
CD Roller Burnished/Shot Peened Rod
Vantage Bolts
CD Horizon- Spinal System
BONE TAP
CD Anterior Spinal System
Cement Restrictor
MEDTRONIC REUSABLE INSTRUMENTS FOR USE WITH THE IPC POWEREASE" SYSTEM
Sovereign
Anatomic Peek
CD Spinal System
Capstone Spinal System
CD HORIZON Spinal System
CAPSTONE Spinal System
Navigated CD HORIZON SOLERA Screwdrivers and Taps
CD HORIZON SOLERA Spinal System
MUTIPLE TYPES OF BURS
ARCHITEX
Navigated Anterolateral Disc Prep Insturments
CD Horizan M8 Screws
CAPSTONE CONTROL Spinal System
CAPSTONE CONTROL PTC Spinal System
COLORADO II Spinal System SS
Navigated Disc Prep Instruments
Spinal System
COLORADO 2 Spinal System
CD Horizon Spinal System
CD HorizonSpinal System
Navigated Vertex Select Drill Bit
Navigated Vertex Select Threaded Driver
Navigated Vertex Select Tap
Medtronic Reusable Instrument
CD HORIZON Threaded Rods
CD Horizon Legacy 6.35 Ti
Vertex Reconstruction Occipital
Verte-Stack Crescent
VERTEX® Reconstruction System
DIVERGENCE Anterior Cervical Fusion System
INFUSE BONGRAFT for Oral Max
MSD Silo Spinal System
CDH Legacy 5.5
VERTE-STACK Spinal System
ENDOSKELETON; TA IBD AND VBR, TO AND TT, TAS, TC, TL
Orfil Spine Fixation system
Galaky Spinal system
CD HORIZON SOLERA SPINAL SYSTEM
TSRH SENTRY VA Screws
TENOR SPINAL SYSDYNA-LOK PLUS Plate
Container
General Instruments
TSRH Open Head Bone Screw
BONE HOOK
MICRO-FRANCE
Lever Screwdriver
KyphX Latitude Curette
KyphX Osteointroducer
Equation Fixation System
Perimeter TI
Tenor Spinal System
CD Engage Cap
Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device
MULTIPLE (CHISELS
OSTEOTOMES)
TSRH Expanded Pedicle Screw
CROSSLINK Plate Non Grooved
Transverse Spinal Fixation
TSRH Osteogrip
Manual surgical instrument for general use
Slap Hammer
POWEREASE System Working Ends
Dynamic Compression Shape Memory
Grafton DBM Plus
Grafton DBM Paste
CD HORIZON® SOLERA® Spinal System
Xantus
NAVIGATED INFINITY Instruments
TSRH Spinal System Prebent/precut r
CD Horizon ModuLeX Spinal System
Bone Graft Washer
CD Horizon ModuLeX FNS Screw Set
ENDOSKELETON® TA nanoLOCK® Surface Technology
CAPSTONE-L SPINAL SYSTEM
CD Horizon Solera HA Screws
ACPii Atlantis Cervial Plate
CD HORIZON SPINAL SYSTEM
CD Horizon Spinal System ; CD Horizon Mazor Modulex Spinal System
Peek Rod
CD HORIZON Longitude 2 Instruments and Rods
T2 Sceptor Universal Endcleats
CD Horizon TAH Pedicle Hooks
Basis Vetebral Body Spacers
CD HORIZON Fenestrated Screw Set
Kyphon HV-R Fenestrated Screw Cement
HourGlass Vertebral Body Spacer
CD Staples and Screws
Clydesdale Spinal System
TENOR Spinal System
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
CD Horizon® Spinal System
CD HORIZON Spinal System, CD HORIZON ESSENTIALS" Spinal System
Dyna-Lok Plate and Screw
Titanium TSRH SpinalSystem
PERIMETER® C
Grafton II eDBM
MagniFuse Bone Graft
MagniFuse
CD Sextant Instruments
Straight Tip Radiance Illumination System
MASTERGRAFT Strip
CD Horizon Minor Mod
CD Horizan Eclipse M8 Screws
Kyphon Xpander II Inflatable Bone Tamp
MASTERGRAFT PUTTY
Anatomic Peek PTC Cervical Fusion System Cage
CD Engage Components
CD Eclipse Screws
ENDOSKELETON(R) TAS
Kyphon
INFINITY Occipitocervical Upper Thoracic System
Dyna-Lok PLUS Spinal System
CD Horizon ModuLeX LigaMAS Head Assm
Pyramid +4 Anterior Lumbar Plate
Verte-Stack Cornerstone Sm End Caps
CD Horizon 6.35 Crosslink Plates
CD Horizon ModuLeX Spinal System - Degen Scoli Phase 2
TSRH 3D Connectors
Orion Anterior Cervical Plate
CD Cobalt Chrome
Pyramid Non-constrained Cover Plate
Expandable Cage
Wave O Spinal System
Verte-Span Lift VB
Dyan-Lok Anterior Posterior Plating
CD HORIZON SPIRE(TM) Z Spinal System
mastergraft
TSRH Crosslink System
Atlas Cable
Townley Pedicle Screw
CD HORIZON Growth Rod Conversion Set
PRESTIGE Cervical Disc
ELEVATE" Spinal System
INFINITY OCT System
Endoskeleton(R) TAS Interbody Fusion Device / Endoskeleton(R) TAS Hyperlordotic Interbody Fusion Device
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
CD Perc Trauma
Vertex Occipital Components
Catalyft LS Expandable Interbody System
CD Horizon Legacy 4.5
Accurian
Perimeter Interbody Fusion Device
ELEVATOR
Bipolar forcep
Kyphon Anchor Facet Screw System
Zephir Anterior Cervical Plate System
Zephir Anterior Cervical Plate
Fuse Spinal System/ PLIF Titanium Cage
TSRH Hook Holder
ENT)
ORTHOPEDIC MANUAL SURGICAL INSTRUM
CRESCENT Vertebral Body Spacer
CD HORIZON VOYAGER"
TSRH Spinal System S Rods and Unit Rods
Sovereign Spinal System
Legacy 6.35 SS
VERTEX SELECT Reconstruction System
Danek Plate and Screw System
Vete-Stack Modified
VERTEX Reconstruction System
VERTEX CROSSLINKS Reconstruction System
Pyramesh C
LT CAGE PEEK
INTERFIX Device (TIBFD)
IB3D PL Spinal System
Tissue Approximating Forceps
FORCEPS (MANUAL INSTRU
MULTIPLE FORCEPS
, MOTORS
DRILLS
SURGICAL DRIVE SYSTEM
X-STOP® Interspinous Spacer Titanium
TSRH Spinal system Crosslink Plates
CEMENT
VERTEBROPLASTY
Soveriegn Spinal System
COLORADO 2 Spinal Sys 6.35 Rods and
Capstone Control Spinal System
TSRH Sentry Anterior/Posterior Spin
PERIMETER Interbody Fusion Device
Verte-Stack XS
LEGEND Power Adapter
CAPSTONE PTC SPINAL SYSTEM
MasterGraft Putty
TSRH TC Threaded Screws
ZEVO Anterior Cervical Plate System
ATLANTIS- Anterior Cervical Plate System
Cement Restrictor Material Peek
VENTURE Anterior Cervical Plate System
POWEREASE System
TSRH L Rod Connector
CD HORIZON VOYAGER Extended Tab Screws
RIALTO SI Fusion System
MULTIPLE (ORTHOPEDIC REAMERS)
CD Horizon Astute Spinal System
ZPlate II
Vertex Cannulated Screw
CD Horizon Spinous Plate
CD Horizon-Spinal System/ CD Horizon SOLERA
CORKSCREW
Grafton DBM
Endoskeleton TCS Interbody Fusion Device
HV-R Bone Cement US
Bone Cement HV-R w/Mixer - US
Danek Sacral Hook
SPINAL INTERVERTEBRAL FUSION
SOLID SPHERE
Transverse Oct Spinal Fixation
Vertex Lateral Connectors
CD HORIZONSpinal System
DanekScope Micro-Endo Systems
MULTIPLE (ORTHOPEDIC OSTEOTOMES)
RETRACTOR
RadiaLux
Spacekeeper
CD Horizon Eclipse Screws
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
CD HORIZON® Fenestrated Screw Set
KYPHON Cement Delivery System
KyphX Bone Filler Device
CD HORIZON(R) Spinal System
T2 STRATOSPHERE Expandable Corpectomy System
CRESENT Ti Spinal System
TSRH Spinal System
Medtronic General Instrument
PIVOX" Oblique Lateral Spinal System
CD Modified Set Screws
Hydrosorb CR
Dyna-lok/Danek Plate Screw
Vertex Keel Plate
SPINE
PLATE
LAMINOPLASTY
T2 STRATSOPHERE Expandable Corpectomy System
CD HORIZON Solera 5.5/6
Danek Infant System
InflateFX
Danek Precision Rod Set
Venture Cervical Plate
CD HORIZON ESSENTIALS Spinal System
CD HORIZON ESSENCE
Kyphon Express Inflatable Bone Tamp
Inflate FX Fracture Management Inflatable Bone Tamp
Kyphon Exact Inflatable Bone Tamp
Pyramesh Implant System
CD HORIZON Spinal System
Premier Anterior Cervical Plate
Variable Angle Screw
PERIMETER INTERBODY FUSION DEVICE
ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD)
CD Horizon Spinal System
surgical instrument
Robotic Graft Delivery Instruments
Kyphon Xpede Bone Cement
CD 4.5 Crosslink Plates
TSRH Spinal System Anterior L Plate
PYRAMID +4 Anterior Lumbar Plate S
GDLH Posterior Spinal System
T2 TXVBR
OsteoCool 2 RF Ablation System
HOLDER, NEEDLE
ICAL INST)
HOLDER NEEDLE
ORTHOPEDIC (ORTHOPEDIC MANUAL SURG
T2 Altitude 1.5 Spinal System
MEROCEL SPONGE
Medtronic Dissector Tool
CD Horizon Ti
CD Horizon MAS Design Enhancement
TSRH 3Dx 90 Degree Offset Connector
COLORADO II Spinal System Ti
SOVEREIGN Spinal System
Plexur P
Vantage Plates
Vertex Max
INFUSE BONEGRAFT/ LT-CAGE Lumbar TF
EEA TAID
Guide Pin; Introducer Tool
DRILL GUIDES
GUIDE WIRES (PINS)
LAA Selection Guide
TSRH Sacral Screw Central Post
Endoskeleton® TAS Interbody Fusion Device
Endoskeleton® TAS Hyperlordotic Interbody Fusion Device And Endoskeleton® TCS Interbody Fusion Device
Curette
ARTHROSCOPE
CD Horizon Advanta
TSRH SENTRY Posterior Spinal System
MASTERGRAFT(TM) BONE VOID FILLER
ENDOSKELETON® TL
ENDOSKELETON(R) TL INTERBODY FUSION DEVICE
Kyphon VuE Bone Cement and Kyphon Mixer Pack
RONGEUR
Loop Spinal System/ TLIF- Cage
MAST QUADRANT Retractor System
T2 XVBR
Cannula; Introducer tool
CD HA Coated
CD Spine Implants for DTT #3
Navigated Elevate Spinal System
CD Spire Spikes
CD Spinal System for DDD TI
CD Horizon Ilio Sacral
Sextant Percutaneous
dilator, lachrymal
General Instrument
PASS LP Spinal System
T2 Sinal System
Endoskeleton TAS Plate
CD Sextant II Reduction
PRESTIGE LP Cervical Disc System
Vertex Adjustable Plate
Crescent Spinal System Interbody F
Kyphon Inflation Syringe
Dyna-Lok Ti Spinal System
Dyna-Lok Classic
CD Central Rod
CD Horizon Modular 5.5/6mm Spinal System
Ti Cement Restrictor
MULTIPLE (DRIVER-EXTRACTORS)
VERTE-STACK(TM)SPINAL SYSTEM
CORNERSTONE PSR Cervical Fusion System
NO 8 HEXALOBE STRAIGHT DRIVER
DIVERGENCE(TM) Anterior Cervical Fusion System
CD Horizon 4.5 Cannulated Screws
Capstone Control
MULTIPLE (SCISSORS)
Tray, Surgical, Instrument
instrument tray
Aspen
Bard-Parker
Wire Nest
SCREWDRIVER
CD Engage Y Parts
ENDOSKELETON TO
Medtronic Transportation/Sterilization Cassettes
Endoskeleton TCS System
AXIS Fixation
Cotrel-Dubousset Spinal System
ROD BENDER
Rasp
Verte-Stack Perimeter Peek
CD HORIZON Spinal System SDS Pre-Bent Rods
PROBE (ORTHOPEDIC MANU
CD Horizon Solera 5.5/6 Sagittal Adjusting Screws
Liberty Anterior System
CD Engage Plate
TSRH Chromaloy Plus Precut Contoured Rods
Mastergraft Contain
Atlas Cable System Ti
TSRH Spinal System 3D Connectors an
Magnifuse II Bone Graft
Anteralign Spinal system with Titan nanoLOCK Surface Technology
CD Horizon Spinal System MAS
Verte-Stack Telamon Ti
CD Horizon 3.2/4.5 Connectors
CD HORIZON Multiaxial screw
MULTIPLE (SURGICAL MALLETS)
Verte-Stack Modified Center Piece
PERIMETER C SPINAL SYSTEM
POWEREASE
ENDOSKELETON TA INTERBODY FUSION DEVICE (IBD
PEEK Prevail Cervical Interbody Dev
Medtronic Reusable Instruments
CD HORIZON SEXTANT II Spinal System
CD HORIZON Spinal System SOLERA
MSB PYRAMESH® Implant System
CORNERSTONEPSR Spinal System
Anteralign Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments
NETTERVILLE LARYNGOLOPLASTIC STAGE
TOWEL
GRIP CLIP - CLIP
MULTIPLE (ORTHOPEDIC CLAMPS)
Liberty Spinal System
CD LIBERTY POSTERIOR SPINCAL SYSTEM
Thoracolumbosacral pedicle screw system
TACOMA Sacral Fixation System
Zplate Anterior Fixation System
TSRH Lateral Offset Plate
SHILLA(TM) Growth Guidance System
Adaptix Interbody System with Titan nanoLock Surface Technology
Danek Unit Rod
BRYAN Cervical Disc
Verte-Stack Perimeter XS
MasterGraft Matrix
CCD Spine System
TSRH TC 3D MPA Screw
Verte-Stack Capstone Peek
Endoskeleton® TO
TSRH Top Tightening T-Bolt
ORION Anterior Cervical
ANTERIOR CERVICAL PLATE SYSTEM
CD Horizon M8 M10 Reduction Hooks
Verte-Span Components
Chisel, Surgical, Manual
Medtronic Transportation_Sterilization Cassettes
SHILLA Growth Guidance System
Multi Axial Screw System
TSRH Offset and Slide Loading Hooks
PERIMETER INSERTER
Dyna-Lok Rods Bolts Connectors
TSRH TC Splined Connectors & Screws
CD Cannulated Screw
SOVEREIGN SPINAL SYSTEM
Verte-Stack T-Peek
CD M8 RMAS
Perimiter C
Multiple High Speed systems
BONE MILL
AFFINITY
CD 5.5mm Set Screws
CD Horizon SMA Staple
SONGER CABLE SYSTEM
SONGER
CD Horizon Antares Spinal System
CROSSLINK Axial & CROSSLINK Offset
Catalyft PL Expandable Interbody System
TSRH Cobalt Chrome Rods
CD Horizan Spinal Ti Spinal System
CD Horizon Reduction
Fuse Spinal System
Pyramid Tapered Shank Bone Screw
Vertex Crosslinks
Atlantis Translational Plate
METRx Endoscope
WRENCH
TRANSLACE Spinal Tethering System
CD Horizon ModuLeX Fenestrated Screw Set
PEEK Previal Cervical Interbody Dev
INFUSE BONEGRAFT Tibial Fracture
Wave D- Spinal System
TSRH Central Post Hooks
TSRH CROSSLINK Axial and Offset Pl
TSRH Spinal System RP
ENDOSKELETON TC
ARTiC-L 3D Ti Spinal System with TiONIC Technology
CD HORIZONSPINAL SYSTEM
Wire Caddy
BONE SCREW RULER
Radio-Opaque Scale
TSRH Silo
Anteralign Spinal System with Titan nanolOCk
Vertex OC MAS, Rods, Hooks
Centerpiece Plate Fixation System
Anatomic Peek- Cervical Fusion System
Crescent
Peek Prevail
Telamon
Clydesdale- Spinal System
Cornerstone PSR
ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS" Anterior Cervical Plate System
CD HORIZON
Titanium GDLH Posterior Spinal Syst
CD Horizon Set Screws
CDH Solera 4.75
CD HORIZON SOLERA"
MULTIPLE (DEPTH GAUGES)
DIVERGENCE-L" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
MASTERGRAFT Putty
Verte-Stack Modified Cornerstone
CD Instrumentation
Mastergraft ( UltraMatrix, Matrix EXT)
MULTIPLE TWIST
Drill; Introducer Tool
BIT DRILLS
DRILL BIT (ORTHOPEDIC MA
CD Ilio Sacral Screws
METRx Microscope
Verte-Stack Clydesdale
TSRH Spinal System 4.5 Screws
NIM SPINE SYSTEM
NIM
MSB-Perimeter System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device