Clearance Summary
Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System received FDA 510(k) clearance under submission number K151064, sponsored by Biomet Spine. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2015-08-12.
- Submission: K151064
- Applicant / Sponsor: Biomet Spine
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2015-08-12
Classification & Regulation
This clearance is catalogued under FDA product code OVE and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.