K241235
- 510(k) number
- K241235
- Device name
- Arthrex TightRope II
- Applicant
- Arthrex, Inc. FL · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2024-05-29
- Date received
- 2024-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241235.pdf
Official FDA record: K241235
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.