510(k) K094017 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
| Applicant | Omni Life Science, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Mar 5, 2010 |
| Received | Dec 29, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K094017
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm
Ref: KC-54010.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | None listed |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm
Ref: KC-54020.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | None listed |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 3 x 4mm
Ref: KC-54030.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | None listed |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm
Ref: KC-54040.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | None listed |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm
Ref: KC-54050.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | None listed |
| Sep 13, 2012 | Omni Life Science Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm
Ref: KC-54060.
The Apex Knee System is intended for use as a primary or revision total knee replacement. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.