Cleared Traditional

MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700

K090112 · Medtronic Powered Surgical Solutions · Neurology
Mar 2009
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K090112 is an FDA 510(k) clearance for the MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Medtronic Powered Surgical Solutions (Fort Worth, US). The FDA issued a Cleared decision on March 26, 2009, 69 days after receiving the submission on January 16, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K090112 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2009
Decision Date March 26, 2009
Days to Decision 69 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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