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
Phone
715 9289253

Products

Device Name Product Code
Screw, Fixation, Bone HWC
Plate, Fixation, Bone HRS
Washer, Bolt Nut HTN
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented LZO
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer KWZ
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) KWA
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented LWJ
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) JDL
Prosthesis, Hip, Hemi-, Femoral, Metal KWL
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented JDI
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented KWY
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented OQH
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented OQI
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented OQG
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented LPH
Rod, Fixation, Intramedullary And Accessories HSB
Wrench HXC
Tap, Bone HWX
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer JWH
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer MBH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive OIY
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented KWS
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
Shoulder Prosthesis, Reverse Configuration PHX
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained PKC
Retractor GAD
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD
Chisel, Surgical, Manual FZO
Bit, Drill HTW
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate MEH
Impactor HWA
Gouge, Surgical, General & Plastic Surgery GDH
Neurological Stereotaxic Instrument HAW
Template HWT
Instrument, Cutting, Orthopedic HTZ
Tape, Orthopedic HXT
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish MAY
Orthopedic Manual Surgical Instrument LXH
Extractor HWB
Gauge, Depth HTJ
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented PAO
Reamer HTO
Hook, Surgical, General & Plastic Surgery GDG
Bit, Surgical GFG
Hammer, Surgical FZY
Awl HWJ
Instrument, Compression HWN
Goniometer, Nonpowered KQW
Forceps HTD
Prosthesis, Hip, Femoral, Resurfacing KXA
Clamp HXD
Guide, Surgical, Instrument FZX
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
Scissors, Orthopedic, Surgical HRR
Vertebral Body Tethering System QHP
Screwdriver HXX
Curette HTF
Cutter, Surgical FZT
Tape, Measuring, Rulers And Calipers FTY
Fastener, Fixation, Nondegradable, Soft Tissue MBI
Tray, Surgical, Instrument FSM
Mixer, Cement, For Clinical Use JDZ
Rasp HTR

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)