Medical Device Manufacturer · US , Warsaw , IN

Zimmer GmbH

43 submissions · 43 cleared · Since 2004
43
Total
43
Cleared
0
Denied

Zimmer GmbH — FDA 510(k) Submissions

Zimmer GmbH has submitted 43 FDA 510(k) premarket notifications since 2004, of which 43 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented, Plate, Fixation, Bone, Rod, Fixation, Intramedullary And Accessories, Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component), Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented . Use the specialty filter in the sidebar to narrow results.

43 devices
1–25 of 43
CoCr Head
K211047 · LPH Prosthesis, Hip,... · Orthopedic
Jan 2023 642d
Affixus(R) Natural Nail(R) System Humeral Nail
K200814 · HSB Rod, Fixation,... · Orthopedic
Apr 2020 29d
Zimmer Hip Joint Replacement
K200112 · LZO Prosthesis, Hip,... · Orthopedic
Apr 2020 84d
Anatomical Shoulder System
K193099 · PHX Shoulder Prosthesis,... · Orthopedic
Jan 2020 83d
Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
K193050 · LZO Prosthesis, Hip,... · Orthopedic
Dec 2019 55d
Avenir Muller Stem, Avenir Cemented Hip Stem
K193030 · LZO Prosthesis, Hip,... · Orthopedic
Dec 2019 37d
Fitmore Hip Stem
K192236 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Nov 2019 78d
Zimmer Natural Nail System Cephalomedullary Nails
K192312 · HSB Rod, Fixation,... · Orthopedic
Oct 2019 46d
BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System
K192416 · LZO Prosthesis, Hip,... · Orthopedic
Oct 2019 27d
NCB Plating System Distal Femur and Proximal Tibia
K192217 · HRS Plate, Fixation, Bone · Orthopedic
Sep 2019 29d
NCB Polyaxial Locking Plate System
K192021 · HRS Plate, Fixation, Bone · Orthopedic
Aug 2019 24d
Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System
K191781 · LZO Prosthesis, Hip,... · Orthopedic
Aug 2019 35d
Affixus Natural Nail System Humeral Nail
K181827 · HSB Rod, Fixation,... · Orthopedic
Dec 2018 158d
Sidus Stem-Free Shoulder
K171858 · PKC Prosthesis, Total... · Orthopedic
Dec 2017 180d
ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System
K170711 · PHX Shoulder Prosthesis,... · Orthopedic
Jun 2017 85d
Fitmore? Hip Stem
K170072 · KWY Prosthesis, Hip, Hemi-,... · Orthopedic
Feb 2017 29d
Anatomical Shoulder Domelock Dome centric
K161620 · HSD Prosthesis, Shoulder,... · Orthopedic
Nov 2016 141d
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis? System
K161192 · LZO Prosthesis, Hip,... · Orthopedic
Jul 2016 72d
Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System
K160085 · KWS Prosthesis, Shoulder,... · Orthopedic
Mar 2016 53d
Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
K142403 · KWS Prosthesis, Shoulder,... · Orthopedic
Nov 2014 89d
AVENIR CEMENTED HIP STEM
K131884 · LZO Prosthesis, Hip,... · Orthopedic
Aug 2013 58d
BIOLOX DELTA CERAMIC FEMORAL HEADS
K130899 · LZO Prosthesis, Hip,... · Orthopedic
May 2013 30d
AVENIR MULLER STEM
K123392 · LZO Prosthesis, Hip,... · Orthopedic
Mar 2013 122d
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
K120715 · HSB Rod, Fixation,... · Orthopedic
Aug 2012 155d
NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATE
K120772 · HRS Plate, Fixation, Bone · Orthopedic
Jun 2012 90d
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