510(k) K193233 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Restoration® Modular Hip System
| Applicant | Howmedica Osteonics Corp. (Aka Stryker Orthopaedics), Mahwah NJ, US |
| Decision | Substantially Equivalent, May 27, 2020 |
| Received | Nov 25, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K193233
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.