K250394
- 510(k) number
- K250394
- Device name
- Fine TTO
- Applicant
- Bodycad Laboratories, Inc. CA
- Product code
- PBF — Orthopaedic Surgical Planning And Instrument Guides
- Decision date
- 2025-10-21
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250394.pdf
Official FDA record: K250394
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.