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

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233261Global Modular Replacement SystemDecember 8, 2023
K210893Restoration Anatomic ShellApril 22, 2021
K203099Triathlon PKR SystemOctober 27, 2020
K191358Trident II Acetabular SystemOctober 24, 2019
K182468Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemMarch 19, 2019
K180612Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsJune 7, 2018
K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsNovember 16, 2017
K171768Trident® II Acetabular SystemOctober 2, 2017
K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsOctober 14, 2016