K243344
- 510(k) number
- K243344
- Device name
- Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures
- Applicant
- Arthrex, Inc. FL · US
- Product code
- JDQ — Cerclage, Fixation
- Decision date
- 2025-02-20
- Date received
- 2024-10-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K243344.pdf
Official FDA record: K243344
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.