510(k) K061648 ยท NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
| Applicant | DePuy Orthopaedics, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 11, 2006 |
| Received | Jun 13, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061648
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 20, 2018 | DePuy Orthopaedics, Inc. (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; Terminated |
HRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.