K251310
- 510(k) number
- K251310
- Device name
- OTS 25-L (100-5)
- Applicant
- Ots Medical , Ltd. IL
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2025-07-22
- Date received
- 2025-04-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K251310.pdf
Official FDA record: K251310
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.