Clearance Summary
EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System received FDA 510(k) clearance under submission number K181603, sponsored by K2m, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2018-10-05.
- Submission: K181603
- Applicant / Sponsor: K2m, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3075
- Decision date: 2018-10-05
Classification & Regulation
This clearance is catalogued under FDA product code NKG and 21 CFR 888.3075, within the Orthopedic review panel as a Class II device.