Medical Device Manufacturer · US , Malwah , NJ

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics

9 submissions · 9 cleared · Since 2016
9
Total
9
Cleared
0
Denied

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics — FDA 510(k) Submissions

Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics has submitted 9 FDA 510(k) premarket notifications since 2016, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented, Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer, Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer, Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
Global Modular Replacement System
K233261 · JDI Prosthesis, Hip,... · Orthopedic
Dec 2023 70d
Restoration Anatomic Shell
K210893 · LPH Prosthesis, Hip,... · Orthopedic
Apr 2021 28d
Triathlon PKR System
K203099 · HSX Prosthesis, Knee,... · Orthopedic
Oct 2020 13d
Trident II Acetabular System
K191358 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2019 156d
Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System
K182468 · LPH Prosthesis, Hip,... · Orthopedic
Mar 2019 190d
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
K180612 · HSX Prosthesis, Knee,... · Orthopedic
Jun 2018 91d
Triathlon? X3? UHMWPE Tibial Inserts and Patellar Components
K172634 · MBH Prosthesis, Knee,... · Orthopedic
Nov 2017 76d
Trident? II Acetabular System
K171768 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2017 110d
Trident? II Tritanium? Acetabular Shells and 6.5 mm Low Profile Hex Screws
K161569 · LPH Prosthesis, Hip,... · Orthopedic
Oct 2016 129d
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