K243470
- 510(k) number
- K243470
- Device name
- Fix2Lock (PEEK Self Punching)
- Applicant
- Osteonic Co., Ltd. KR
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2024-12-03
- Date received
- 2024-11-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K243470.pdf
Official FDA record: K243470
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.