K250424
- 510(k) number
- K250424
- Device name
- Arthrex TightRope Soft Button, RT
- Applicant
- Arthrex, Inc. FL · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-03-11
- Date received
- 2025-02-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250424.pdf
Official FDA record: K250424
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.