K250095
- 510(k) number
- K250095
- Device name
- All-Suture Dual Anchor System
- Applicant
- Suturetech, Inc. NC · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-09-05
- Date received
- 2025-01-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250095.pdf
Official FDA record: K250095
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.