Clearance Summary
SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 received FDA 510(k) clearance under submission number K120557, sponsored by Biomet Spine & Bone Healing Technologies. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2012-03-19.
- Submission: K120557
- Applicant / Sponsor: Biomet Spine & Bone Healing Technologies
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2012-03-19
Classification & Regulation
This clearance is catalogued under FDA product code OVD and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.