K232492
- 510(k) number
- K232492
- Device name
- 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite Anchor
- Applicant
- Medos International SARL CH
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2023-10-06
- Date received
- 2023-08-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K232492.pdf
Official FDA record: K232492
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.