Clearance Summary
VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 received FDA 510(k) clearance under submission number K002990, sponsored by Vascular Technology Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2000-11-06.
- Submission: K002990
- Applicant / Sponsor: Vascular Technology Incorporated
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4460
- Decision date: 2000-11-06
Classification & Regulation
This clearance is catalogued under FDA product code HBL and 21 CFR 882.4460, within the Neurology review panel as a Class II device.