510(k) K962137 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
GENESIS II CONSTRAINED SYSTEM
| Applicant | Smith & Nephew Richards, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Aug 2, 1996 |
| Received | Jun 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 21, 2020 | Smith & Nephew, Inc. Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral a Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.