K252054
- 510(k) number
- K252054
- Device name
- SpineAR SNAP (SyncAR Spine)
- Applicant
- Surgical Theater, Inc. OH · US
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2025-09-29
- Date received
- 2025-07-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K252054.pdf
Official FDA record: K252054
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.