K250613
- 510(k) number
- K250613
- Device name
- SnapHammer Hammertoe Correction System
- Applicant
- Nvision Biomedical Technologies, Inc. TX · US
- Product code
- HWC — Screw, Fixation, Bone
- Decision date
- 2025-04-02
- Date received
- 2025-02-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250613.pdf
Official FDA record: K250613
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.