510(k) K191569 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Implantcast ic-Bipolar Head System
| Applicant | Implantcast GmbH, Buxtehude, DE |
| Decision | Substantially Equivalent, Aug 28, 2019 |
| Received | Jun 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191569
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.