510(k) K043346 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00
| Applicant | Genesis Medical LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, Jan 31, 2005 |
| Received | Dec 6, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043346
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.