LORENZ DISTRACTION SYSTEM

External Mandibular Fixator And/or Distractor

WALTER LORENZ SURGICAL, INC.

The following data is part of a premarket notification filed by Walter Lorenz Surgical, Inc. with the FDA for Lorenz Distraction System.

Pre-market Notification Details

• Device ID: K992952
• 510k Number: K992952
• Device Name: LORENZ DISTRACTION SYSTEM
• Classification: External Mandibular Fixator And/or Distractor
• Applicant: WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218
• Contact: Diana Preston
• Correspondent: Diana Preston; WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218
• Product Code: MQN
• CFR Regulation Number: 872.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-09-01
• Decision Date: 1999-11-19
• Summary: summary

NIH GUDID Devices

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