Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics - FDA 510(k) Cl...
Recent clearances: Global Modular Replacement System, Restoration Anatomic Shell, Triathlon PKR System
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics Orthopedic ✕
9 devices
Cleared
Dec 08, 2023
Global Modular Replacement System
Orthopedic
70d
Cleared
Apr 22, 2021
Restoration Anatomic Shell
Orthopedic
28d
Cleared
Oct 27, 2020
Triathlon PKR System
Orthopedic
13d
Cleared
Oct 24, 2019
Trident II Acetabular System
Orthopedic
156d
Cleared
Mar 19, 2019
Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II...
Orthopedic
190d
Cleared
Jun 07, 2018
Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
Orthopedic
91d
Cleared
Nov 16, 2017
Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
Orthopedic
76d
Cleared
Oct 02, 2017
Trident® II Acetabular System
Orthopedic
110d
Cleared
Oct 14, 2016
Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws
Orthopedic
129d