LORENZ RESORBABLE DISTRACTOR SYSTEM

Plate, Bone

WALTER LORENZ SURGICAL, INC.

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

Pre-market Notification Details

• Device ID: K002083
• 510k Number: K002083
• Device Name: LORENZ RESORBABLE DISTRACTOR SYSTEM
• Classification: Plate, Bone
• Applicant: WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218
• Contact: Steve Herrington
• Correspondent: Steve Herrington; WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DR. Jacksonville, FL 32218
• Product Code: JEY
• CFR Regulation Number: 872.4760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-07-10
• Decision Date: 2001-02-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841036090654	K002083	000
00841036055226	K002083	000
00841036055219	K002083	000
00841036055196	K002083	000
00841036055165	K002083	000
00841036055158	K002083	000
00841036055134	K002083	000
00841036055127	K002083	000
00841036055103	K002083	000
00841036055097	K002083	000
00841036055080	K002083	000
00841036055073	K002083	000
00841036055066	K002083	000
00841036055059	K002083	000
00841036055042	K002083	000
00841036055028	K002083	000
00841036055004	K002083	000
00841036055233	K002083	000
00841036055271	K002083	000
00841036090647	K002083	000
00841036089535	K002083	000
00841036089283	K002083	000
00841036072025	K002083	000
00841036070472	K002083	000
00841036063689	K002083	000
00841036061081	K002083	000
00841036056131	K002083	000
00841036056124	K002083	000
00841036056117	K002083	000
00841036134365	K002083	000
00841036070731	K002083	000
00841036066451	K002083	000
00841036055424	K002083	000
00841036055417	K002083	000
00841036055400	K002083	000
00888233025218	K002083	000