K250297
- 510(k) number
- K250297
- Device name
- TECHFIT Patient-Specific Cranial System
- Applicant
- Techfit Digital Surgery, Inc. FL · US
- Product code
- GWO — Plate, Cranioplasty, Preformed, Alterable
- Decision date
- 2025-10-27
- Date received
- 2025-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250297.pdf
Official FDA record: K250297
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.