Cleared Traditional

Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories

K163182 · Medtronic Powered Surgical Solutions · Neurology
Mar 2017
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K163182 is an FDA 510(k) clearance for the Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories, 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 23, 2017, 129 days after receiving the submission on November 14, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4370.

Submission Details

510(k) Number K163182 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2016
Decision Date March 23, 2017
Days to Decision 129 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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