Cleared Traditional

LORENZ FIDUCAIL SCREW

K010427 · Walter Lorenz Surgical, Inc. · Neurology
Mar 2001
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K010427 is an FDA 510(k) clearance for the LORENZ FIDUCAIL SCREW, a Neurological Stereotaxic Instrument (Class II — Special Controls, product code HAW), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 15, 2001, 30 days after receiving the submission on February 13, 2001. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K010427 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2001
Decision Date March 15, 2001
Days to Decision 30 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HAW — Neurological Stereotaxic Instrument
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4560

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