FDA Registration
Active
🇺🇸 United States
WARSAW ORTHOPEDIC, INC.
Reg #: 1824199
·
FEI: 1824199
·
Expires 2026
Products
84
Proprietary Names
361
Establishment Types
4
Classifications
84
Registration Details
- Registration Name
- WARSAW ORTHOPEDIC, INC.
- Registration Number
- 1824199
- FEI Number
- 1824199
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2500 SILVEUS CROSSING
- City
- WARSAW
- State
- IN
- ZIP
- 46582
- Country
- US
Regulatory Submissions
- 510(k) Number
- K050981
- PMA Number
- P000028
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 |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2008-01-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2008-01-31 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2008-01-31 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2008-01-31 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2008-01-31 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-02-18 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-06-07 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2022-06-07 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2008-02-01 |
| Implant, Fixation Device, Spinal | JDN | Class 2 | Orthopedic | No | 2008-01-30 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-06-11 |
| Growing Rod System | PGM | Class 2 | Orthopedic | No | 2015-12-08 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2020-03-31 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2009-12-16 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2008-02-05 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2016-02-26 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2006-06-29 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2015-06-23 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2008-01-31 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2016-10-17 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Prosthesis, Hip, Cement Restrictor | JDK | Class 2 | General, Plastic Surgery | No | 2008-01-31 |
| Motor, Surgical Instrument, Ac-Powered | GEY | Class 1 | General, Plastic Surgery | No | 2001-03-30 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2006-06-29 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2015-03-02 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2008-02-27 |
| Wire, Surgical | LRN | Class 2 | Orthopedic | No | 2008-02-05 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2008-02-05 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2008-02-04 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2005-05-31 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2020-10-06 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2020-10-06 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2005-05-31 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2015-02-03 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2002-11-19 |
| Wrench | HXC | Class 1 | Orthopedic | No | 1992-12-12 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2007-03-08 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 1992-12-12 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1992-12-12 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2008-01-31 |
| Crimper, Pin | HXQ | Class 1 | Orthopedic | No | 2002-11-19 |
| Prosthesis, Finger, Polymer | KWF | Class 2 | Orthopedic | No | 2008-01-31 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2003-05-08 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2014-08-10 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-06-29 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2002-11-19 |
| Light, Surgical, Carrier | FSZ | Class 2 | General, Plastic Surgery | No | 2018-12-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2008-01-31 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2001-03-30 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2012-05-10 |
| Bender | HXW | Class 1 | Orthopedic | No | 1992-12-12 |
| Template | HWT | Class 1 | Orthopedic | No | 2006-05-17 |
| Filler, Bone Void, Calcium Compound | MQV | Class 2 | Orthopedic | No | 2008-02-06 |
| Driver, Prosthesis | HWR | Class 1 | Orthopedic | No | 1978-02-15 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2011-04-19 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2011-04-19 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2005-03-23 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2008-02-01 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 1994-11-09 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2008-02-04 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2008-01-17 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2008-01-25 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 1978-02-15 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Mesh, Surgical, Metal | EZX | Class 2 | General, Plastic Surgery | No | 2008-02-01 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 1995-03-03 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Knife, Orthopedic | HTS | Class 1 | Orthopedic | No | 2006-06-29 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 1992-12-12 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 1992-12-12 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2006-06-29 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar | NVR | Class 3 | Unknown | No | 2007-03-08 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2005-05-31 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2004-08-18 |
| Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction | NEK | Class 3 | Unknown | No | 2008-03-31 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2005-05-31 |
| Probe | HXB | Class 1 | Orthopedic | No | 2006-06-29 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2005-05-31 |
Proprietary Names
CD Engage Components
Vertex Reconstruction System
CD HORIZON Spinal System
CD Horizon ModuLeX Spinal System
TSRH 3Dx 90 Degree Offset Connector
CD Horizon® Spinal System
Verte-Span Components
CDH Solera 4.75
CD HORIZON SOLERA"
Venture Cervical Plate
CD Instrumentation
TSRH Lateral Offset Plate
Atlantis Vision Anterior Cervical
Wave D- Spinal System
Transverse Oct Spinal Fixation
CD HORIZON Growth Rod Conversion Set
CD Horizon TAH Pedicle Hooks
CD HORIZON SPINAL SYSTEM
TSRH Spinal System S Rods and Unit Rods
VERTEX® Reconstruction System
Bipolar forcep
AFFINITY
Basis Vetebral Body Spacers
Dyna-Lok Plate and Screw
TSRH Spinal System 3D Connectors an
TSRH
Atlas Cable System Ti
CD HA Coated
CDH Legacy 5.5
RIALTO" SI FUSION SYSTEM
NAVIGATED INFINITY Instruments
TSRH Open Head Bone Screw
Vertex Cannulated Screw
Titanium TSRH SpinalSystem
ELEVATOR
T2 Sceptor Universal Endcleats
Vertex Reconstruction Occipital
Zplate Anterior Fixation System
Transverse Spinal Fixation
CLYDESDALE Spinal System
HOLDER, NEEDLE
ICAL INST)
HOLDER NEEDLE
ORTHOPEDIC (ORTHOPEDIC MANUAL SURG
Fuse Spinal System
ELEVATE" Spinal System
Dyna-Lok Classic
Vertex Crosslinks
Vertex Max
CD Horizan M8 Screws
Pyramid Tapered Shank Bone Screw
Vertex Lateral Connectors
Pyramesh C
CD Horizon Spinal System
CD HORIZON Longitude 2 Instruments and Rods
CD HORIZON® Spinal System
DIVERGENCE-L" ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
CD Modified Set Screws
CD Ilio Sacral Screws
NETTERVILLE LARYNGOLOPLASTIC STAGE
TOWEL
GRIP CLIP - CLIP
MULTIPLE (ORTHOPEDIC CLAMPS)
TSRH TC 3D MPA Screw
RIALTO SI Fusion System
BONE HOOK
MICRO-FRANCE
CD Cobalt Chrome
CD Spinal System
CD Spire Spikes
Threaded Cement Restrictor Ti
Multiple High Speed systems
BONE MILL
TSRH Spinal System
CD HORIZON Multiaxial screw
MULTIPLE TWIST
Drill; Introducer Tool
BIT DRILLS
DRILL BIT (ORTHOPEDIC MA
CD Horizon SMA Staple
CD M8 RMAS
Soveriegn Spinal System
Legacy 6.35 SS
PRESTIGECervical Disc
BRYANCervical Disc System
CD HORIZON® Fenestrated Screw Set
KYPHON Cement Delivery System
KyphX Bone Filler Device
Atlas Cable
Perimeter Interbody Fusion Device
CD HORIZON Threaded Rods
DanekScope Micro-Endo Systems
TSRH Spinal System RP
Townley Transfacetpedicular Screw
Equation Fixation System
CRESCENT SPINAL SYSTEM TITANIUM
ELEVATE SPINAL SYSTEM
CRESCENT SPINAL SYSTEM
CAPSTONE PTC SPINAL SYSTEM
Ti Cement Restrictor
MULTIPLE (SCISSORS)
CD Horizon Advanta
Verte-Span Lift VB
Pyramid +4 Anterior Lumbar Plate
MULTIPLE (DRIVER-EXTRACTORS)
IB3D PL Spinal System
DIVERGENCE Anterior Cervical Fusion System
Medtronic Reusable Instrument
WRENCH
Sextant Percutaneous
PRESTIGE LP Cervical Disc System
TSRH Crosslink System
CD 5.5mm Set Screws
ACPii Atlantis Cervial Plate
Vantage Bolts
SPINE
PLATE
LAMINOPLASTY
T2 TXVBR
Variable Angle Screw
CAPSTONE Spinal System
Galaky Spinal system
CD HORIZON SOLERA Spinal System
TSRH Sacral Screw Central Post
Thoracolumbosacral pedicle screw system
CD Horizon Ilio Sacral
Pyramid Non-constrained Cover Plate
TSRH SENTRY Posterior Spinal System
Catalyft PL Expandable Interbody System
SCREWDRIVER
COLORADO II Spinal System Ti
CD Horizon Reduction
CD HORIZON
CD Engage Cap
Wire Caddy
BONE SCREW RULER
Radio-Opaque Scale
TSRH CROSSLINK Axial and Offset Pl
CD Horizon Legacy 6.35 Ti
MUTIPLE TYPES OF BURS
DIVERGENCE(TM) Anterior Cervical Fusion System
CD Horizon Spinal System MAS
CD Horizon 3.2/4.5 Connectors
CD Horizan Spinal Ti Spinal System
MSD Silo Spinal System
Vertex Keel Plate
Loop Spinal System/ TLIF- Cage
VERTEX Reconstruction System
TSRH Cobalt Chrome Rods
CD Engage Plate
PYRAMID +4 Anterior Lumbar Plate S
CD Horizon Minor Mod
Dyna-Lok Rods Bolts Connectors
TSRH Silo
CD 4.5 Crosslink Plates
Dyna-Lok PLUS Spinal System
EEA TAID
Guide Pin; Introducer Tool
DRILL GUIDES
GUIDE WIRES (PINS)
LAA Selection Guide
CD Horizon Astute Spinal System
CCD Spine System
CD Cannulated Screw
CD Horizon Eclipse Screws
General Instrument
PASS LP Spinal System
CD HORIZON Solera 5.5/6
GDLH Posterior Spinal System
TSRH Spinal System 4.5 Screws
CD HORIZON® SOLERA® Spinal System
Straight Tip Radiance Illumination System
Hydrosorb CR
Tray, Surgical, Instrument
instrument tray
Aspen
Bard-Parker
Wire Nest
Vantage Plates
POWEREASE
VERTE-STACK(TM)SPINAL SYSTEM
TSRH Spinal System MPA Screws
TEMPLATE
METRx Endoscope
TSRH Spinal System Prebent/precut r
TENOR SPINAL SYSDYNA-LOK PLUS Plate
CD Engage Y Parts
CD Perc Trauma
Vertex Occipital Components
CD Horizon MAS Design Enhancement
MASTERGRAFT PUTTY
Vertex OC MAS, Rods, Hooks
CD Horizon Solera HA Screws
SOVEREIGN Spinal System
VERTEX CROSSLINKS Reconstruction System
MSB PYRAMESH® Implant System
Peek Rod
COLORADO II Spinal System SS
PRESTIGE Cervical Disc
Dyna-lok/Danek Plate Screw
TENOR Spinal System
MODIFICATION TO TENOR SPINAL SYSTEM-PLATES
Tenor Spinal System
CD HORIZON VOYAGER Extended Tab Screws
ARCHITEX
CD Horizon Set Screws
CD Horizon Legacy 4.5
RETRACTOR
RadiaLux
Spacekeeper
ATLANTIS- Anterior Cervical Plate System
Dynamic Compression Shape Memory
PERIMETER® C
MEROCEL SPONGE
Medtronic Dissector Tool
MAST QUADRANT Retractor System
Fuse Spinal System/ PLIF Titanium Cage
TSRH Expanded Pedicle Screw
TSRH Sentry Anterior/Posterior Spin
CD Horizon Spinal System
Atlantis Translational Plate
Verte-Stack Telamon Ti
VERTEX SELECT Reconstruction System
CD Horizon 4.5 Cannulated Screws
NIM SPINE SYSTEM
NIM
Lever Screwdriver
KyphX Latitude Curette
KyphX Osteointroducer
TSRH Hook Holder
CROSSLINK Axial & CROSSLINK Offset
ATLANTIS Anterior Cervical Plate System, ATLANTIS ESSENTIALS" Anterior Cervical Plate System
CD Horizon M8 M10 Reduction Hooks
CD Anterior Spinal System
Capstone Spinal System
CEMENT
VERTEBROPLASTY
TSRH TC Threaded Screws
ZPlate II
AXIS Fixation
BONE TAP
Danek Infant System
Zephir Anterior Cervical Plate System
Zephir Anterior Cervical Plate
TSRH Spinal System Anterior L Plate
Verte-Stack Capstone Peek
MULTIPLE (CHISELS
OSTEOTOMES)
Pyramesh Implant System
CD Horizon 3.5 Rods
CD Horizon- Spinal System
PEEK Prevail Cervical Interbody Dev
BRYAN Cervical Disc
TSRH Offset and Slide Loading Hooks
Orfil Spine Fixation system
CD Horizon Solera 5.5/6 Sagittal Adjusting Screws
Navigated Vertex Select Drill Bit
Navigated Vertex Select Threaded Driver
Navigated Vertex Select Tap
CD Horizon Spinous Plate
CD HORIZONSPINAL SYSTEM
UCSS Non-Cannulated
ARTHROSCOPE
CD HORIZON Spinal System SOLERA
Vertex Adjustable Plate
TSRH Spinal system Crosslink Plates
MULTIPLE (ORTHOPEDIC OSTEOTOMES)
CD Horizon Antares Spinal System
CD Modified Sextant II Instruments
CD HORIZON SPIRE(TM) Z Spinal System
ENT)
ORTHOPEDIC MANUAL SURGICAL INSTRUM
Multi Axial Screw System
COLORADO 2 Spinal System
COLORADO 2 Spinal Sys 6.35 Rods and
INFINITY OCT System
Perimeter TI
CD Horizan Eclipse M8 Screws
ZEVO Anterior Cervical Plate System
Expandable Cage
Wave O Spinal System
Liberty Spinal System
CD LIBERTY POSTERIOR SPINCAL SYSTEM
VERTEX
CD HorizonSpinal System
CD Sextant II Reduction
Cement Restrictor
Dyna-Lok Ti Spinal System
Spinal System
METRx Microscope
CD Eclipse Screws
CD HORIZON ESSENTIALS Spinal System
CD HORIZON ESSENCE
ORION Anterior Cervical
ANTERIOR CERVICAL PLATE SYSTEM
ROD BENDER
Dyan-Lok Anterior Posterior Plating
PEEK Previal Cervical Interbody Dev
Tissue Approximating Forceps
FORCEPS (MANUAL INSTRU
MULTIPLE FORCEPS
CD Staples and Screws
TSRH L Rod Connector
TSRH Central Post Hooks
CD HORIZON Spinal System
Cotrel-Dubousset Spinal System
Liberty Anterior System
CD Spine Implants for DTT #3
LT CAGE PEEK
INTERFIX Device (TIBFD)
CROSSLINK Plate Non Grooved
CD HORIZON Spinal System SDS Pre-Bent Rods
Titanium GDLH Posterior Spinal Syst
Danek Unit Rod
CRESENT Ti Spinal System
CD Sextant Instruments
CD Horizon Eclipse
CD HORIZONSpinal System
CD Horizon-Spinal System/ CD Horizon SOLERA
PIVOX" Oblique Lateral Spinal System
Verte-Stack Perimeter Peek
TACOMA Sacral Fixation System
TSRH Top Tightening T-Bolt
CD Horizon 6.35 Crosslink Plates
INFINITY Occipitocervical Upper Thoracic System
Danek Precision Rod Set
MULTIPLE (SURGICAL MALLETS)
PERIMETER C SPINAL SYSTEM
Sovereign
, MOTORS
DRILLS
SURGICAL DRIVE SYSTEM
Townley Pedicle Screw
CD Roller Burnished/Shot Peened Rod
SPINAL INTERVERTEBRAL FUSION
SOLID SPHERE
TSRH TC Splined Connectors & Screws
Bone Graft Washer
T2 Sinal System
TSRH SENTRY VA Screws
CD HORIZON Spinal System, CD HORIZON ESSENTIALS" Spinal System
TSRH Chromaloy Plus Precut Contoured Rods
RONGEUR
Premier Anterior Cervical Plate
MULTIPLE (ORTHOPEDIC REAMERS)
CD Horizon Ti
CD Central Rod
VENTURE Anterior Cervical Plate System
Danek Plate and Screw System
Medtronic General Instrument
TSRH 3D Connectors
INFUSE BONEGRAFT/ LT-CAGE Lumbar TF
CD HORIZON(R) Spinal System
CD Spinal System for DDD TI
MULTIPLE (DEPTH GAUGES)
CD Horizon Ballast" Spinal System
CD HORIZON SOLERA SPINAL SYSTEM
PROBE (ORTHOPEDIC MANU
Orion Anterior Cervical Plate
spinal system
TSRH Osteogrip
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