510(k) K153345 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Stryker Orthopaedics Hip Systems Labeling Update
| Applicant | Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, May 25, 2016 |
| Received | Nov 19, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153345
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2016 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp. Terminated |
HWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.