K241234
- 510(k) number
- K241234
- Device name
- OTS 25-L (100-5)
- Applicant
- Ots Medical , Ltd. IL
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-01-23
- Date received
- 2024-05-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241234.pdf
Official FDA record: K241234
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.