510(k) K243623 ยท SBF Orthopedic Augmented Reality
SpineAR SNAP (SyncAR Spine)
| Applicant | Surgical Theater, Inc., Beachwood OH, US |
| Decision | Substantially Equivalent, Dec 24, 2024 |
| Received | Nov 25, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243623
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2025 | Surgical Theater Inc SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality Terminated |
SFB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.