K250477
- 510(k) number
- K250477
- Device name
- NextAR(TM) Spine
- Applicant
- Medacta International S.A. CH
- Product code
- SBF — Orthopedic Augmented Reality
- Decision date
- 2025-07-31
- Date received
- 2025-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250477.pdf
Official FDA record: K250477
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.