Cleared Traditional

OSSEODUO Shaver and Drill System

K173066 · Bien-Air Surgery SA · Neurology
Jun 2018
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K173066 is an FDA 510(k) clearance for the OSSEODUO Shaver and Drill System, a Motor, Drill, Electric (Class II — Special Controls, product code HBC), submitted by Bien-Air Surgery SA (Le Noirmont, CH). The FDA issued a Cleared decision on June 22, 2018, 266 days after receiving the submission on September 29, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4360.

Submission Details

510(k) Number K173066 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2017
Decision Date June 22, 2018
Days to Decision 266 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBC — Motor, Drill, Electric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4360

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