Clearance Summary
VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX received FDA 510(k) clearance under submission number K022241, sponsored by Vertis Neuroscience, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-09-11.
- Submission: K022241
- Applicant / Sponsor: Vertis Neuroscience, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2002-09-11
Classification & Regulation
This clearance is catalogued under FDA product code NHI and 21 CFR 882.5890, within the Neurology review panel as a Class II device.