Clearance Summary
BIODRIVE MICRO SCREW SYSTEM received FDA 510(k) clearance under submission number K092670, sponsored by Ebi,Llc D/B/A Biomet Trauma. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2009-11-19.
- Submission: K092670
- Applicant / Sponsor: Ebi,Llc D/B/A Biomet Trauma
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2009-11-19
Classification & Regulation
This clearance is catalogued under FDA product code HRS and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.