United Orthopedic Knee Patient Specific Instrumentation is an AI-enabled medical device from Enhatch, Inc., listed by FDA (510(k), K230850) with a decision date of 2023-12-20. Review panel: Orthopedic.
| FDA submission number | K230850 |
|---|---|
| Pathway | 510(k) |
| Company | Enhatch, Inc. |
| Review panel (specialty) | Orthopedic |
| FDA decision date | 2023-12-20 |
| Decision | Substantially Equivalent |
| Product code | OOG |
| Classification | Knee Arthroplasty Implantation System |
| Device class | 2 |
| Regulation number | 888.3560 |
| Review time (calendar days) | 267 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
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Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.