K233429
- 510(k) number
- K233429
- Device name
- OTS 25 (100-1)
- Applicant
- Ots Medical , Ltd. IL
- Product code
- MBI — Fastener, Fixation, Nondegradable, Soft Tissue
- Decision date
- 2023-12-07
- Date received
- 2023-10-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K233429.pdf
Official FDA record: K233429
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.