Clearance Summary
Bio2 Fusion Implant System received FDA 510(k) clearance under submission number K151876, sponsored by Bio2 Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-12-30.
- Submission: K151876
- Applicant / Sponsor: Bio2 Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3040
- Decision date: 2015-12-30
Classification & Regulation
This clearance is catalogued under FDA product code HTY and 21 CFR 888.3040, within the Orthopedic review panel as a Class II device.