K253727
- 510(k) number
- K253727
- Device name
- Syndesmosis TightRope PRO
- Applicant
- Arthrex, Inc. FL · US
- Product code
- HTN — Washer, Bolt Nut
- Decision date
- 2025-12-22
- Date received
- 2025-11-24
- 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: K253727.pdf
Official FDA record: K253727
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.