Cleared Traditional

SYNTHES AIR PEN DRIVE (APD) SYSTEM

K093361 · Synthes (Usa) · Neurology
Apr 2010
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K093361 is an FDA 510(k) clearance for the SYNTHES AIR PEN DRIVE (APD) SYSTEM, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Synthes (Usa) (19380, US). The FDA issued a Cleared decision on April 14, 2010, 168 days after receiving the submission on October 28, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K093361 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 2009
Decision Date April 14, 2010
Days to Decision 168 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBB — Motor, Drill, Pneumatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4370

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