Clearance Summary
VERTEBRAL ACCESS SYSTEM BY VIDACARE received FDA 510(k) clearance under submission number K081713, sponsored by Vidacare Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2008-11-21.
- Submission: K081713
- Applicant / Sponsor: Vidacare Corporation
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 2008-11-21
Classification & Regulation
This clearance is catalogued under FDA product code MOQ and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.