510(k) K130635 ยท HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
SEVIIN SURFACE REPLACEMENT SHOULDER
| Applicant | Ingen Orthopedics, LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, Aug 26, 2013 |
| Received | Mar 11, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130635
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.