510(k) K210153 ยท SBF Orthopedic Augmented Reality
NextAR RSA Platform
| Applicant | Medacta International S.A., Castel San Pietro (Ch), CH |
| Decision | Substantially Equivalent, May 12, 2021 |
| Received | Jan 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210153
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2022 | Medacta Usa Inc NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid Terminated |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.