Panels › Orthopedic › Product code OOG · Class 2
Knee Arthroplasty Implantation System
Regulation 888.3560
0510(k)s in 12 months (2 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in OOG
| Company | 510(k)s | Recalls |
|---|---|---|
| Conformis, Inc. | 1 | 3 |
| Enhatch, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iUNI Unicondylar Knee Replacement System
iUNI G2, Right Lateral
Catalog Number: M57220600240 (US)
M5722INT0600240 (OUS) Terminated |
OOG | K132640 K133256 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS Unicondylar Knee Replacement System
iUNI G2, Left Medial
Catalog Number: M57220600210(US)
M5722INT0600210 (OUS) Terminated |
OOG | K132640 K133256 |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iUni Unicondylar Knee Replacement System:
iUNI G2, Left Lateral
Catalog Number: M57220600230 (US)
M5722INT0600230 (OUS) Terminated |
OOG | K132640 K133256 |
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