510(k) K081448 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
ENCORE SHOULDER REVISION GLENOID
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Sep 30, 2008 |
| Received | May 23, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081448
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2009 | Encore Medical, Lp Turon Revision Glenoid Poly Liner.
The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate Terminated |
MBF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.