Clearance Summary
ALEUTIAN SPACER, MODEL K2-07-1004-01, K2-07-1005-01 received FDA 510(k) clearance under submission number K080024, sponsored by K2m, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2008-01-24.
- Submission: K080024
- Applicant / Sponsor: K2m, Inc.
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3060
- Decision date: 2008-01-24
Classification & Regulation
This clearance is catalogued under FDA product code MQP and 21 CFR 888.3060, within the Orthopedic review panel as a Class II device.