Clearance Summary
Prime BIOFOAM® Multi-Hole Shells received FDA 510(k) clearance under submission number K201157, 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 2021-08-24.
- Submission: K201157
- Applicant / Sponsor: Microport Orthopedics, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3358
- Decision date: 2021-08-24
Classification & Regulation
This clearance is catalogued under FDA product code MBL and 21 CFR 888.3358, within the Orthopedic review panel as a Class II device.