Clearance Summary
BENVENUE VCF OSTEO COIL SYSTEM received FDA 510(k) clearance under submission number K070293, sponsored by Benvenue 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 2007-07-10.
- Submission: K070293
- Applicant / Sponsor: Benvenue Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4540
- Decision date: 2007-07-10
Classification & Regulation
This clearance is catalogued under FDA product code OCJ and 21 CFR 888.4540, within the Orthopedic review panel as a Class I device.