K252657
- 510(k) number
- K252657
- Device name
- Impact PEEK Union Nail System
- Applicant
- Nvision Biomedical Technologies, Inc. TX · US
- Product code
- HTY — Pin, Fixation, Smooth
- Decision date
- 2025-09-19
- Date received
- 2025-08-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K252657.pdf
Official FDA record: K252657
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.