Clearance Summary
SAGICO IBF SYSTEM ARIA LUMBAR, SAGICO IBF SYSTEM ARION CERVICAL received FDA 510(k) clearance under submission number K161710, sponsored by Spinal Analytics & Geometrical Impant Co, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2017-06-29.
- Submission: K161710
- Applicant / Sponsor: Spinal Analytics & Geometrical Impant Co, LLC
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3080
- Decision date: 2017-06-29
Classification & Regulation
This clearance is catalogued under FDA product code MAX and 21 CFR 888.3080, within the Orthopedic review panel as a Class II device.