510(k) K133256 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
| Applicant | Conformis, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Jan 9, 2014 |
| Received | Oct 23, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133256
| 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 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2, Left Lateral
Catalog Number: M57230600230 Terminated |
NPJ | None listed |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial
Catalog Number: M57230600220 (US)
M5723INT0600220 (OUS) Terminated |
NPJ | None listed |
| Oct 21, 2015 | ConforMIS, Inc. ConFormis iDUO G2, Right Lateral
Catalog Number: M5723INT0600240 (US)
M5723INT0600240 (OUS) Terminated |
NPJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.