K250921
- 510(k) number
- K250921
- Device name
- CORIOGRAPH Pre-Op Planning and Modeling Services
- Applicant
- Blue Belt Technologies, Inc. PA · US
- Product code
- PBF — Orthopaedic Surgical Planning And Instrument Guides
- Decision date
- 2025-06-25
- Date received
- 2025-03-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.2 MB · U.S. public domain
Also available from FDA: K250921.pdf
Official FDA record: K250921
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.