510(k) K132640 ยท HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM
| Applicant | Conformis, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Dec 5, 2013 |
| Received | Aug 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132640
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iUni Unicondylar Knee Replacement System:
iUNI G2, Left Lateral
Catalog Number: M57220600230 (US)
M5722INT0600230 (OUS) Terminated |
OOG | None listed |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS Unicondylar Knee Replacement System
iUNI G2, Left Medial
Catalog Number: M57220600210(US)
M5722INT0600210 (OUS) Terminated |
OOG | None listed |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iUNI Unicondylar Knee Replacement System
iUNI G2, Right Lateral
Catalog Number: M57220600240 (US)
M5722INT0600240 (OUS) Terminated |
OOG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.