510(k) K222632 ยท KWL Prosthesis, Hip, Hemi-, Femoral, Metal
UHR Bipolar Implants, Restoration GAP II Implants
| Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 21, 2022 |
| Received | Aug 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222632
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.