K261770
- 510(k) number
- K261770
- Device name
- Suture Button Repair System
- Applicant
- Skeletal Dynamics, Inc. FL · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-07-29
- Date received
- 2026-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K261770.pdf
Official FDA record: K261770
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.