Cleared Special

Stryker Maestro Air Motors

K150801 · Stryker Corporation · Neurology
May 2015
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K150801 is an FDA 510(k) clearance for the Stryker Maestro Air Motors, a Motor, Drill, Pneumatic (Class II — Special Controls, product code HBB), submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on May 22, 2015, 57 days after receiving the submission on March 26, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K150801 FDA.gov
FDA Decision Cleared SESE
Date Received March 26, 2015
Decision Date May 22, 2015
Days to Decision 57 days
Submission Type Special
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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