510(k) K213129 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Restoration Modular 115mm Conical Distal Stem
| Applicant | Howmedica Osteonics Corp., Dba Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Dec 21, 2021 |
| Received | Sep 27, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213129
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.