K250528
- 510(k) number
- K250528
- Device name
- Stryker AlphaVent Knotless SP Biocomposite Anchor
- Applicant
- Stryker Endoscopy CA · US
- Product code
- MAI — Fastener, Fixation, Biodegradable, Soft Tissue
- Decision date
- 2025-05-21
- Date received
- 2025-02-24
- 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: K250528.pdf
Official FDA record: K250528
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.