Clearance Summary
D4000 DRIVE SYSTEM; D4000A DRIVE SYSTEM WITH IRRIGATION received FDA 510(k) clearance under submission number K130497, sponsored by Linvatec Corporation D/B/A Conmed Linvatec. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2013-03-29.
- Submission: K130497
- Applicant / Sponsor: Linvatec Corporation D/B/A Conmed Linvatec
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.4360
- Decision date: 2013-03-29
Classification & Regulation
This clearance is catalogued under FDA product code HBC and 21 CFR 882.4360, within the Neurology review panel as a Class II device.