K250646
- 510(k) number
- K250646
- Device name
- Impact PEEK Union Nail System
- Applicant
- Nvision Biomedical Technologies TX · US
- Product code
- HTY — Pin, Fixation, Smooth
- Decision date
- 2025-06-11
- Date received
- 2025-03-04
- 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: K250646.pdf
Official FDA record: K250646
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.