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

Device Identifier	submissionNumber	Supplement
00841036010607	K992952	000
00841036066659	K992952	000
00841036068394	K992952	000
00841036069841	K992952	000
00841036069889	K992952	000
00841036071363	K992952	000
00841036072421	K992952	000
00841036072759	K992952	000
00841036073602	K992952	000
00841036074739	K992952	000
00841036074746	K992952	000
00841036074753	K992952	000
00841036074760	K992952	000
00841036074777	K992952	000
00841036065935	K992952	000
00841036064457	K992952	000
00841036010614	K992952	000
00841036010652	K992952	000
00841036010669	K992952	000
00841036010676	K992952	000
00841036010683	K992952	000
00841036010690	K992952	000
00841036010850	K992952	000
00841036010904	K992952	000
00841036010911	K992952	000
00841036010928	K992952	000
00841036057398	K992952	000
00841036057428	K992952	000
00841036057435	K992952	000
00841036079901	K992952	000
00841036084660	K992952	000
00841036128975	K992952	000
00841036132262	K992952	000
00841036136031	K992952	000
00841036137038	K992952	000
00841036137175	K992952	000
00841036143848	K992952	000
00841036144678	K992952	000
00841036146238	K992952	000
00841036150525	K992952	000
00841036151300	K992952	000
00841036151317	K992952	000
00841036157081	K992952	000
00841036162078	K992952	000
00841036127732	K992952	000
00841036127725	K992952	000
00841036084776	K992952	000
00841036086152	K992952	000
00841036086183	K992952	000
00841036090975	K992952	000
00841036122812	K992952	000
00841036122836	K992952	000
00841036123437	K992952	000
00841036124229	K992952	000
00841036125073	K992952	000
00841036125387	K992952	000
00841036125486	K992952	000
00841036125790	K992952	000
00841036126681	K992952	000
00841036193379	K992952	000