FDA Registration
Active
🇨🇭 Switzerland
ZIMMER GMBH
Reg #: 9613350
·
FEI: 3005233524
·
Expires 2026
Products
63
Proprietary Names
100
Establishment Types
2
Classifications
63
Registration Details
- Registration Name
- ZIMMER GMBH
- Registration Number
- 9613350
- FEI Number
- 3005233524
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Sulzer Allee 8
- City
- WINTERTHUR Zurich
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K192021
Owner / Operator
- Firm Name
- ZIMMER GMBH
- Operator Number
- 9064978
- Address
- Zahlerweg 4
- City
- Zug
- State
- CH-ZG
- Postal Code
- 6300
- Country
- CH
US Agent
- Business Name
- Zimmer Biomet
- Contact Name
- Stephanie Lynch
- Address
- 1800 W Center St
- City
- Warsaw
- State
- IN
- ZIP
- 46580
- Country
- US
- [email protected]
- Phone
- 715 9289253
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-08-26 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-08-26 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2012-06-18 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2008-05-07 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2008-05-07 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | KWA | Class 3 | Orthopedic | No | 2008-05-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2008-05-07 |
| Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | JDL | Class 3 | Orthopedic | No | 2008-05-07 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2008-05-07 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2008-05-07 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2008-05-07 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2020-08-05 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2020-08-05 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2020-08-05 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2020-08-05 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2023-09-22 |
| Wrench | HXC | Class 1 | Orthopedic | No | 1996-04-08 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2007-05-15 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-10-08 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-10-08 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2021-10-08 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2007-12-05 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2007-12-05 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2007-12-05 |
| Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | PKC | Class 2 | Orthopedic | No | 2017-12-22 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1996-04-08 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2007-12-05 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1997-03-19 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 1996-04-09 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2019-12-23 |
| Impactor | HWA | Class 1 | Orthopedic | No | 1996-04-09 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 1996-04-08 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2007-12-03 |
| Template | HWT | Class 1 | Orthopedic | No | 1996-04-09 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 1996-04-08 |
| Tape, Orthopedic | HXT | Class 1 | General, Plastic Surgery | No | 2020-02-10 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2020-02-28 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 1996-04-09 |
| Extractor | HWB | Class 1 | Orthopedic | No | 1996-04-09 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 1996-04-09 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | PAO | Class 2 | Orthopedic | No | 2020-02-04 |
| Reamer | HTO | Class 1 | Orthopedic | No | 1996-04-09 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 1996-04-08 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 1996-04-09 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 1996-04-08 |
| Awl | HWJ | Class 1 | Orthopedic | No | 1996-04-09 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 1996-04-09 |
| Goniometer, Nonpowered | KQW | Class 1 | Orthopedic | No | 2007-01-03 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 1996-04-08 |
| Prosthesis, Hip, Femoral, Resurfacing | KXA | Class 2 | Orthopedic | No | 2007-05-15 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 1996-04-08 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 1996-04-09 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 1996-04-09 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 1996-04-08 |
| Vertebral Body Tethering System | QHP | Class N | Unknown | No | 2020-07-08 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1996-04-09 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 1996-04-08 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 1996-04-09 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2008-02-29 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2016-03-30 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1996-04-09 |
| Mixer, Cement, For Clinical Use | JDZ | Class 1 | Orthopedic | No | 1996-04-09 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 1996-04-09 |
Proprietary Names
NCB Polyaxial Locking Plate System
NCB Periprosthetic Trochanter Plates and Screws
NCB Cable Button for NCB Polyaxial Locking Plate
Fitmore
Z Porolock MIS Stem
Zimmer, Inc. Hip Joint Prostheses MR Labeling I
Zimmer Natural Nail System Cephalomedullary Nails
BIOLOX DELTA CERAMIC HEADS
Zimmer GmbH
Persona® Personalized Knee System (Flexion First Instruments)
Normed Vario Subtalar Screw
Anatomical Shoulder Inverse/Reverse
Sidus Stem-Free Shoulder
NCB Plating Sys, Proximal Tibia Pla
CLS Stem, Wagner Rev Stem, Alloclas
NCB Periprosthetic Fumur Polyaxial Locking Plate System
Anatomical Shoulder Fracture System
ARCOMXL Polyethylene Liners and BIOLOX Delta Heads
Anatomical Shoulder System, Domelock and Fracture System
Persona Revision SoluTion Femoral Components
Persona® Revision Knee System
Gruber Lapidus Tarsalis Plates and Screws
Sirus Intramedullary Nail-Fem & Tib
Avenir Complete Hip System, Size I Coxa Vera
Wagner SL Revison Awls
Recon System-Compression Screws
Z1 Cemented Hip System
Normed
Zweymueller-SL Hip Prosthesis Stem
Navitrack System:Total Hip Replacem
Affixus® Natural Nail® System Humeral Nail
TMARS Provisional Template
ZIMMER BIOMET
Zimmer Biomet Ceramic Heads
Wagner Revision Stem (modification)
Biolox Delta Ceramic Femoral Heads - Compatability
Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads
Avenir Muller Stem
Anatomical Shoulder System
Alloclassic Zweymueller SL/SLL Femo
Zweymueller SL Femoral Hip Stem
Anatomical Shoulder TM Combined System
Affixus Natural Nail Proximal Humeral System
BIOLOX(R) DELTA CERAMIC HEADS
Fitmore Hip Stem
Avenir Complete Hip System
Anatomical Shoulder Keeled Glenoid
Affixus Humeral Stem
ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System
Anatomical Shoulder Domelock Dome Centric
NCB Straight Narrow Shaft Plates
Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
NCB Plating System
RECON System - MPJ Plates
ZNN Cephalomedullary Nails
Zimmer GmbH Hip Joint Replacement-MR Labeling
Wagner Revision Stem
Modified Alloclassic Zweymuller SL
Zimmer Biomet Select Ceramic Heads
Durom Hip Resurfacing Sys, Fem Comp
Anatomical Shoulder System, Anatomical Shoulder Domelock, Anatomical Shoulder Fracture System
Wagner SL Revision Stem Lateral
Biolox delta Ceramic Femoral Head
BIOLOX DELTA OPTION CERAMIC HEADS
NCB Plating System Distal Femur and Proximal Tibia
Wagner SL and Wagner Cone Stems
CLS Hip Prosthesis
Anatomical Shoulder with Removable
Anatomical Press-Fit Humeral Stem
INTER-OP DURASUL ACETABULAR INSERTS/COCR FEMORAL HEADS
NCB® Straight Narrow Shaft Plate
NCB® Cable Button
NCB® Periprosthetic Femur Plate System
NCB® Polyaxial Locking Plate System;
Biolox Delta Ceramic Femoral Heads, Biolox Option Ceramic Femoral Head System
Trabecular Metal Acetabular Revision
Avenir Cemented Hip Stem
BIOLOX DELTA CERAMIC OPTION HEADS
The Tether - Vertebral Body Tethering System
CLS Brevius Stem with Kinectiv Technology
Anatomica Glenoid Component
Wagner Cone Prosthesis System
CoCr Head
Wagner Cone Prosthesis
ZNN Cephalomedullary Femoral Nail-Asia
Tenodesis
Z Trabecular Metal Reverse Shoulder
Biolox Option
Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head
Wagner Revision Femoral Hip Prosthe
RECON System
NORMED ANKLE FIX SYSTEM 4 AND NORMED ANKLE FIX PLUS SYSTEM 4
Persona Personalized Knee System
Sulzer Ortho MS-30 Femoral Stem
V-TEK IVP
Locking Plate System
NCB Periprosthetic Femur Polyaxial
NCB Poly Locking Plate Z ULS 3.5mm
Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling
Avenir Muller Stem, Avenir Cemented Hip Stem
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)