510(k) K212941 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Porous Patella
| Applicant | Encore Medical, L.P. Dba Djo Surgical, Austin TX, US |
| Decision | Substantially Equivalent, Jan 20, 2022 |
| Received | Sep 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212941
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2023 | Encore Medical, LP EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108 Open, Classified |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.