Cleared Traditional

LEGEND POWER ADAPTER MODEL: 6475000

K101168 · Medtronic Sofamor Danek · Neurology
Aug 2010
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K101168 is an FDA 510(k) clearance for the LEGEND POWER ADAPTER MODEL: 6475000, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on August 24, 2010, 120 days after receiving the submission on April 26, 2010. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K101168 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2010
Decision Date August 24, 2010
Days to Decision 120 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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