Clearance Summary
ADVANCED TURBO DRIVE SYSTEM received FDA 510(k) clearance under submission number K050519, sponsored by Linvatec Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2005-05-17.
- Submission: K050519
- Applicant / Sponsor: Linvatec Corp.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4820
- Decision date: 2005-05-17
Classification & Regulation
This clearance is catalogued under FDA product code GEY and 21 CFR 878.4820, within the General, Plastic Surgery review panel as a Class I device.