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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 20, 2023 | K230850 | United Orthopedic Knee Patient Specific Instrumentation Enhatch, Inc. | OOG |
| Apr 19, 2021 | K203421 | Triathlon AS-1 Conformis, Inc. | OOG |
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