Clearance Summary
POLARIS SPINAL SYSTEM, POLARIS/SYNERGY STRUCTUE ANTERIOR FIXATION SYSTEM received FDA 510(k) clearance under submission number K100409, sponsored by Biomet Spine (Aka Ebi, LLC). The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2010-06-23.
- Submission: K100409
- Applicant / Sponsor: Biomet Spine (Aka Ebi, LLC)
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3070
- Decision date: 2010-06-23
Classification & Regulation
This clearance is catalogued under FDA product code NKB and 21 CFR 888.3070, within the Orthopedic review panel as a Class II device.