Clearance Summary
OTS 25 (100-1) received FDA 510(k) clearance under submission number K233429, sponsored by Ots Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2023-12-07.
- Submission: K233429
- Applicant / Sponsor: Ots Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2023-12-07
Classification & Regulation
This clearance is catalogued under FDA product code MBI and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.