K253718
- 510(k) number
- K253718
- Device name
- enHAnce PEEK Bunion System
- Applicant
- Nvision Biomedical Technologies, Inc. TX · US
- Product code
- HRS — Plate, Fixation, Bone
- Decision date
- 2026-04-01
- Date received
- 2025-11-24
- 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: K253718.pdf
Official FDA record: K253718
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.