K253040
- 510(k) number
- K253040
- Device name
- Aevumed FASE Suture Anchor
- Applicant
- Aevumed, Inc. PA · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-10-21
- Date received
- 2025-09-22
- 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: K253040.pdf
Official FDA record: K253040
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.