510(k) K023087 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Dec 16, 2002 |
| Received | Sep 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023087
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2024 | Howmedica Osteonics Corp. Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00; Open, Classified |
JDI | None listed |
| Sep 29, 2010 | Stryker Howmedica Osteonics Corp. GMRS Extension Piece, 60 mm; Sterile
Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland.
The Global Modular Replacement System is intended to be used with the components Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.