Cleared Traditional

STRYKER TWIST DRILLS

K070876 · Stryker Craniomaxillofacial · Neurology
Apr 2007
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K070876 is an FDA 510(k) clearance for the STRYKER TWIST DRILLS, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Stryker Craniomaxillofacial (Portage, US). The FDA issued a Cleared decision on April 27, 2007, 29 days after receiving the submission on March 29, 2007. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K070876 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2007
Decision Date April 27, 2007
Days to Decision 29 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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