510(k) K130299 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
GMK HINGE
| Applicant | Medacta International, Camarillo CA, US |
| Decision | Substantially Equivalent, Aug 15, 2013 |
| Received | Feb 7, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130299
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 12, 2017 | Medacta Usa Inc Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H, STERILE EO Terminated |
KRO | None listed |
| Nov 14, 2015 | Medacta Usa GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery Terminated |
KRO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.