Clearance Summary
EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base received FDA 510(k) clearance under submission number K152298, sponsored by Microport Orthopedics, 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 2015-11-16.
- Submission: K152298
- Applicant / Sponsor: Microport Orthopedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3565
- Decision date: 2015-11-16
Classification & Regulation
This clearance is catalogued under FDA product code MBH and 21 CFR 888.3565, within the Orthopedic review panel as a Class II device.