Cleared Special

QUICKSET MIMIX BONE VOID FILLER

K023718 · Walter Lorenz Surgical, Inc. · Neurology
Dec 2002
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K023718 is an FDA 510(k) clearance for the QUICKSET MIMIX BONE VOID FILLER, a Methyl Methacrylate For Cranioplasty (Class II — Special Controls, product code GXP), submitted by Walter Lorenz Surgical, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 4, 2002, 29 days after receiving the submission on November 5, 2002. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5300.

Submission Details

510(k) Number K023718 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2002
Decision Date December 04, 2002
Days to Decision 29 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXP — Methyl Methacrylate For Cranioplasty
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5300

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