K243790
- 510(k) number
- K243790
- Device name
- GRYPHON X Anchor; HEALIX TRANSTEND Anchor
- Applicant
- Depuy Mitek MA · US
- Product code
- MAI — Fastener, Fixation, Biodegradable, Soft Tissue
- Decision date
- 2025-02-05
- Date received
- 2024-12-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243790.pdf
Official FDA record: K243790
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.