Cleared Traditional

CONMED LINVATEC OSPREY DRILL SYSTEM

K080444 · Conmed Linvatec · Neurology
Apr 2008
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K080444 is an FDA 510(k) clearance for the CONMED LINVATEC OSPREY DRILL SYSTEM, a Motor, Drill, Electric (Class II — Special Controls, product code HBC), submitted by Conmed Linvatec (Largo, US). The FDA issued a Cleared decision on April 2, 2008, 43 days after receiving the submission on February 19, 2008. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number K080444 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2008
Decision Date April 02, 2008
Days to Decision 43 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBC — Motor, Drill, Electric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4360

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