Clearance Summary
b-ONE® Bipolar Head received FDA 510(k) clearance under submission number K253357, sponsored by B-One Ortho, Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2026-04-13.
- Submission: K253357
- Applicant / Sponsor: B-One Ortho, Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3390
- Decision date: 2026-04-13
Classification & Regulation
This clearance is catalogued under FDA product code KWY and 21 CFR 888.3390, within the Orthopedic review panel as a Class II device.