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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K002083
Device Name LORENZ RESORBABLE DISTRACTOR SYSTEM
Applicant
Walter Lorenz Surgical, Inc.
1520 Tradeport Dr.
Jacksonville,  FL  32218
Applicant Contact STEVE HERRINGTON
Correspondent
Walter Lorenz Surgical, Inc.
1520 Tradeport Dr.
Jacksonville,  FL  32218
Correspondent Contact STEVE HERRINGTON
Regulation Number872.4760
Classification Product Code
JEY  
Date Received07/10/2000
Decision Date 02/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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