Clearance Summary
ACCELL EVO3 (FORMERLY ACCELL A2I) received FDA 510(k) clearance under submission number K103742, sponsored by Integra Life Sciences. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2011-03-17.
- Submission: K103742
- Applicant / Sponsor: Integra Life Sciences
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3045
- Decision date: 2011-03-17
Classification & Regulation
This clearance is catalogued under FDA product code MBP and 21 CFR 888.3045, within the Orthopedic review panel as a Class II device.