K241010
- 510(k) number
- K241010
- Device name
- HEALIX ADVANCE Knotless anchors; HEALIX ADVANCE Self-Punching anchors
- Applicant
- Depuy Mitek MA · US
- Product code
- MAI — Fastener, Fixation, Biodegradable, Soft Tissue
- Decision date
- 2024-09-11
- Date received
- 2024-04-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K241010.pdf
Official FDA record: K241010
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.