510(k) K042343 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
SCORPIO NRG KNEE SYSTEM
| Applicant | Howmedica Osteonics Corp., Mahwah NJ, US |
| Decision | Substantially Equivalent, Feb 9, 2005 |
| Received | Aug 30, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042343
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2015 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Scorpio femoral component.
Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile.
For use in total reconstructive replacement of the knee joint. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.