510(k) K110598 ยท PHX Shoulder Prosthesis, Reverse Configuration
SMR REVERSE SHOULDER SYSTEM
| Applicant | Lima Corporate S.P.A., Winona Lake IN, US |
| Decision | Substantially Equivalent, Aug 18, 2011 |
| Received | Mar 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110598
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2016 | Limacorporate S.p.A SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement. Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.