510(k) K103117 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
| Applicant | Conformis, Inc., Burlington MA, US |
| Decision | Substantially Equivalent, Jan 7, 2011 |
| Received | Oct 21, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103117
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 17, 2012 | Conformis Inc Conformis iTotal CR-Cruciate Retaining Knee Replacement System
Model Numbers:
M57250600010 iTotal CR, Left Knee
M57250600020 iTotal CR, Right Knee
Product Usage : Usage:
The iTotal CR Knee Replac Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.