FDA Registration
Active
🇺🇸 United States
ZIMMER SURGICAL, INC.
Reg #: 1526350
·
FEI: 1526350
·
Expires 2026
Products
32
Proprietary Names
173
Establishment Types
5
Classifications
32
Registration Details
- Registration Name
- ZIMMER SURGICAL, INC.
- Registration Number
- 1526350
- FEI Number
- 1526350
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 200 WEST OHIO AVE.
- City
- Dover
- State
- OH
- ZIP
- 44622
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172481
Owner / Operator
- Firm Name
- ZIMMER, INC.
- Operator Number
- 1822565
- Address
- 345 E. Main Street, --
- City
- Warsaw
- State
- IN
- Postal Code
- 46580
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | Class 2 | General, Plastic Surgery | No | 2018-06-28 |
| Saw, Powered, And Accessories | HAB | Class 1 | General, Plastic Surgery | No | 2012-03-14 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2017-10-31 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2006-05-26 |
| Tourniquet, Pneumatic | KCY | Class 1 | General, Plastic Surgery | No | 2001-05-22 |
| Gown, Surgical | FYA | Class 2 | General, Plastic Surgery | No | 2019-10-18 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2001-05-22 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2003-07-02 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2021-05-25 |
| Evacuator, Vapor, Cement Monomer | JDY | Class 1 | Orthopedic | No | 2006-01-30 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2006-01-30 |
| Expander, Surgical, Skin Graft | FZW | Class 1 | General, Plastic Surgery | No | 1984-12-17 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 1986-12-30 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2003-07-02 |
| Spatula, Surgical, General & Plastic Surgery | GAF | Class 1 | General, Plastic Surgery | No | 1978-03-07 |
| Battery, Replacement, Rechargeable | MOQ | Class 1 | General, Plastic Surgery | No | 2012-03-14 |
| Positioner, Socket | KIL | Class 1 | Orthopedic | No | 2006-05-26 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2026-01-20 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2007-11-07 |
| Prosthesis, Elbow, Semi-Constrained, Cemented | JDB | Class 2 | Orthopedic | No | 2007-11-07 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 1978-02-06 |
| Operating Room Accessories Table Tray | FWZ | Class 1 | General, Plastic Surgery | No | 2001-05-22 |
| Washer Of Body Waste Receptacles | FLH | Class 1 | General Hospital | No | 2012-11-07 |
| Cement Obturator | LZN | Class 2 | General, Plastic Surgery | No | 2007-11-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2007-11-07 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2011-03-31 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2011-03-31 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2011-03-31 |
| Dermatome | GFD | Class 1 | General, Plastic Surgery | No | 1984-12-17 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 2005-04-15 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 1999-05-20 |
| Hood, Surgical | FXY | Class 2 | General, Plastic Surgery | No | 2023-12-14 |
Proprietary Names
intelliCart
Intellicart
Various bat. and pneum. powered sys., access., attachments
UNIVERSAL Intramedullary Attachment
UNIVERSAL Dedicated Oscillating Handpiece
UNIVERSAL Ream Attachment
UNIVERSAL Drill Attachment
AO/Hudson Adapter
UNIVERSAL Pneumatic Hose
UNIVERSAL Electric Power Supply
Modular Coupling
UNIVERSAL Key Chuck Attachment
Washing Caps Sets
UNIVERSAL Modular Pneumatic Trigger Handpiece
UNIVERSAL Modular Electric/Battery Trigger Handpiece
Power cord
Key for Key Chuck Attachment
Powered Saw and Accessories
UNIVERSAL Saw Attachment
UNIVERSAL Dedicated Reciprocating Handpiece
UNIVERSAL Sterilizable Cord for Electric Power Supply
UNIVERSAL Adapter for Pneumatic Hose
O-Ring for Pneumatic Hose
UNIVERSAL Wire Driver
Zimmer Biomet X Series
CONTINUUM KNEE SYSTEM (CKS)
BONE HARVESTER
Ultra battery powerd system, accessories, and attachments
Battery Powered System, accessories, and attachments
Hose with CPC connector
IV Pole / Rollstand
Single Port/Dual Bladder Disposable Cuff with PLC
Tank Holder
Dual Port/Single Bladder Disposable Cuff
Dual Port, Single Bladder cuff with PLC and protective sleeve
Dual Port/Dual Bladder Disposable Cuff
Single Port/Single Bladder Contour Lge Thigh Cuff
ATS Cyclindrical Cuff, Single Port/Dual Bladder
Dual Port/Single Bladder Contour Lge Thigh Cuff
Basket
ATS Cylindrical Cuff, Single Port/Single Bladder
Retrofit Kit
Single Port, Single Bladder cuff with PLC and protective sleeve
Dual Port, Dual Bladder, cuff with PLC and protective sleeve
Single Port/Dual Bladder Disposable Cuff
Protective sleeve for Disposable Cuff
ATS Tourniquet Systems
Luer Adaptors
Single Port/Single Bladder Disposable Cuff
Stand Base
Hoses
ATS Cylindrical Cuff, Dual Port/Dual Bladder
ATS Cylindrical Cuff, Dual Port/Single Bladder
Pulsavac tip with shield
Pulsavac tip with filter
Pulsavac Tips
Pulsavac Plus Wound Debridement System
Pulsavac Power supply
Pulsavac Splash Shields
Pulsavac Plus Low Pressure Wound Debridement Systems
Pulsavac Connectors
Pulsavac Plus AC Wound Debridement System
Curette
MONOMER EVACUATIONG BOWL
SUPER BOWL
Zimmer Vacuum Foot Pumps
ICLH (FREEMAN) ANKLE
ActiveCare+SFT; ActiveCare+SFT HomeCare
ZIMMER CEMENT DISPENS
INTRODIGITATOR
Breakaway Nozzle
ZIMMER BONE CEMENT INJECTOR
Meshgraft II Dermatome with Ratchet
Meshgraft II Ratchet Handle
Zimmer Skin Graft Mesher with Autoclave case and Rachet Handle
Zimmer Skin Graft Mesher
Meshgraft II
Dermacarrier II Skin Graft Carrrier
Cysto Adapters
Specimen Socks
Y Tube 8 Ft
Specimen Trap
Collector Roll stand
Disposable Canister and Lid
Powered IV pole
UL PP100R
CL-200 Cart Lid
Hemovac, Drain with Trocar
Surgivac PVC with Trocar
Universal Y-Connector
Compact Evacuator, PVC with Trocar
Mini-Snyder Hemovac Evacuator
Suction Adaptor
PVC Drains with and without Trocar
CL500 Ultra Cart Manifold and Cover
Infection Control Evacuator, Drain with Bonded Suction Port
TP-TUB160 Tandum Tubing
Y-Connector Silicone
DL-2800 Disposable Lid
Bifurcated Drain Extension
Y-Tube -Short
Evacuators and Tubing, Y Connectors for Drains
T-Tube Long
Directional Flow Control
Evacuators and Collection Bags, PVC w/ Trocar
Tri-Tube
Evacuator Tubing
2800cc Disposable Collector
Silicone Drain with and without Trocar
1800cc Reusable Collector
Evacuators w/ Anti Reflux Valves
Quad Lumen Drain with Trocar
2800cc Reusable Collector
Infection Control Kit
Compact Evacuator, Silicone with Trocar
1800cc Disposable Collector
Compact Evacuator, Drain with Bonded Suction Port
450ml Bag
Mini Snyder Hemovac Infection Control Kit
Keels
Procedure Pack
Raps
OSCILLATING SAW BLADE
STABLECUT
RECIPROCATING SAW BLADE
Zimmer
Universal Funnel for Aseptic Transfer Kit
Universal Battery for Aseptic Transfer Kit
Universal Flash Battery
Universal Compact Battery Charger
Universal Complete Aseptic Transfer Kit with Battery
Positioner, Socket
Protective sleeve for Disposable Cuff
ATS Cylindrical Cuff, Single Port/Dual Bladder
Single Port, Single Bladder Cuff with PLC and protective sleeve
Various Models ATS with LOP Sensor
ATS4000TS Tourniquet System
Single Port/Dual BLadder Disposable Cuff
Dual Port, Dual Bladder, Cuff with PLC and protective sleeve
Luer Adapters
IntelliCart OUS
OptiVu Streamer
Coonrad/Morrey Elbow Cement Restric
Zim Clip
Mini-Clips
MASON LEG HOLDER
Wilson Convex Frame
Alvarado Knee Support and Stabilizing Plate
Alvarado Leg Holder II
ActiveCare DVT and ActiveCare+SFT System
Transposal Safety Station
Allen Med Cement Plugs, Z Poly Plug
Anatomical Shoulder Combined System
Zimmer Dermatome AN
Z Dermatome Blade
DERMATONE-AIR OR ELECTRIC POWERED
Zimmer Air Dermatome II Handpiece
Zimmer Dermatome II Blade
Air Dermatome II Hose
Dermatome Screwdriver
Zimmer Dermatome II Screwdriver
Zimmer Derm II Width Plate
Dermatome Hose
Air Dermatome Handpiece
Zimmer Dermatome Blade
Width Plate
Dermatome Autoclave Case
Automatic Tourniquet System ATS5000
DISPOSABLE MIXING BOWL
3 Dose Compact Mixer
Compact Vacuum Cement Mixing System
Zimmer Power-Mix Vacuum Cement Mixing System
PSN Valgus Alignment Guide
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only