K252081
- 510(k) number
- K252081
- Device name
- SportLinc Syndesmosis Device
- Applicant
- Lincotek Medical TN · US
- Product code
- HTN — Washer, Bolt Nut
- Decision date
- 2026-03-27
- Date received
- 2025-07-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K252081.pdf
Official FDA record: K252081
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.