Cleared Special

ADVANCED TURBO DRIVE SYSTEM

K050519 · Linvatec Corp. · General & Plastic Surgery
May 2005
Decision
77d
Days
Class 1
Risk

About This 510(k) Submission

K050519 is an FDA 510(k) clearance for the ADVANCED TURBO DRIVE SYSTEM, a Motor, Surgical Instrument, Ac-powered (Class I — General Controls, product code GEY), submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on May 17, 2005, 77 days after receiving the submission on March 1, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K050519 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2005
Decision Date May 17, 2005
Days to Decision 77 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code GEY — Motor, Surgical Instrument, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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