K254306
- 510(k) number
- K254306
- Device name
- Aevumed FENIX Suture Anchor
- Applicant
- Aevumed, Inc. PA · US
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2026-03-04
- Date received
- 2025-12-31
- 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: K254306.pdf
Official FDA record: K254306
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.