Clearance Summary
MICROFUSE PUTTY AND MICROFUSE ST MIS received FDA 510(k) clearance under submission number K102392, sponsored by Globus Medical, 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 2010-12-22.
- Submission: K102392
- Applicant / Sponsor: Globus Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2010-12-22
Classification & Regulation
This clearance is catalogued under FDA product code MQV and 21 CFR 888.3045, within the Orthopedic review panel as a Class II device.