K253693
- 510(k) number
- K253693
- Device name
- Strut Suture; No-Tie Button
- Applicant
- Riverpoint Medical, LLC OR · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-03-11
- Date received
- 2025-11-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K253693.pdf
Official FDA record: K253693
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.