510(k) K131277 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
SEVIIN FRACTURE SHOULDER
| Applicant | Ingen Orthopedics, LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, Aug 28, 2013 |
| Received | May 6, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131277
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.