510(k) K051976 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
PROVEN REVISION MODULAR TIBIAL TRAY
| Applicant | Stelkast Company, Mcmurray PA, US |
| Decision | Substantially Equivalent, Oct 17, 2005 |
| Received | Jul 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051976
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | None listed |
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5, Size 2 Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | None listed |
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5, Size 3, Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | None listed |
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5, Size 4, Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | None listed |
| Jan 23, 2008 | Stelkast Co StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number: SC2287-5-5, Size 5, Thickness 5 mm, StelKast, Murray, PA 15317 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.