Cleared Special

LORENZE EXTERNAL MANDIBULAR DISTRACTOR

K031696 · Walter Lorenz Surgical, Inc. · Dental
Jun 2003
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K031696 is an FDA 510(k) clearance for the LORENZE EXTERNAL MANDIBULAR DISTRACTOR, a External Mandibular Fixator And/or Distractor (Class II — Special Controls, product code MQN), submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 17, 2003, 15 days after receiving the submission on June 2, 2003. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.

Submission Details

510(k) Number K031696 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2003
Decision Date June 17, 2003
Days to Decision 15 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MQN — External Mandibular Fixator And/or Distractor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4760

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