Clearance Summary
ACTIFUSE BONE GRAFT SUBSTITUTE AND E-Z-FIL AND SHAPE BONE GRAFT SUBSTITUTE received FDA 510(k) clearance under submission number K081979, sponsored by Apatech , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2008-11-06.
- Submission: K081979
- Applicant / Sponsor: Apatech , Ltd.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2008-11-06
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.