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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, fixation, bone
510(k) Number K011354
Device Name HIGH TIBIAL OSTEOTOMY PLATING SYSTEM
Applicant
DJ ORTHOPEDICS, LLC
990 PARK CENTER DRIVE, SUITE H
VISTA,  CA  92083
Applicant Contact JAMAL D RUSHDY
Correspondent
DJ ORTHOPEDICS, LLC
990 PARK CENTER DRIVE, SUITE H
VISTA,  CA  92083
Correspondent Contact JAMAL D RUSHDY
Regulation Number888.3030
Classification Product Code
HRS  
Date Received05/03/2001
Decision Date 07/31/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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