Cleared Traditional

OsteoMed PINNACLE Driver

K162542 · Osteomed · Neurology
May 2017
Decision
249d
Days
Class 2
Risk

About This 510(k) Submission

K162542 is an FDA 510(k) clearance for the OsteoMed PINNACLE Driver, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on May 19, 2017, 249 days after receiving the submission on September 12, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K162542 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2016
Decision Date May 19, 2017
Days to Decision 249 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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