510(k) K121640 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Dec 5, 2012 |
| Received | Jun 4, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 21, 2014 | Materialise USA LLC Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperat Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.