510(k) K113756 ยท OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Mar 14, 2012 |
| Received | Dec 21, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113756
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2024 | Encore Medical, LP REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 Completed |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.