Clearance Summary
b-ONE® Total Hip System received FDA 510(k) clearance under submission number K240528, 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 2024-11-15.
- Submission: K240528
- Applicant / Sponsor: B-One Ortho, Corp.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3353
- Decision date: 2024-11-15
Classification & Regulation
This clearance is catalogued under FDA product code LZO and 21 CFR 888.3353, within the Orthopedic review panel as a Class II device.