Cleared Traditional

TWIST DRILL

K062842 · Walter Lorenz Surgical, Inc. · Neurology
Dec 2006
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K062842 is an FDA 510(k) clearance for the TWIST DRILL, a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II — Special Controls, product code HBE), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on December 4, 2006, 73 days after receiving the submission on September 22, 2006. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number K062842 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2006
Decision Date December 04, 2006
Days to Decision 73 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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