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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K003960
Device Name DJ ORTHOPEDICS TIBIAL ANCHOR
Applicant
Dj Orthopedics, LLC
990 Park Center Dr., Suite H
Vista,  CA  92083
Applicant Contact JAMAL D RUSHDY
Correspondent
Dj Orthopedics, LLC
990 Park Center Dr., Suite H
Vista,  CA  92083
Correspondent Contact JAMAL D RUSHDY
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received12/21/2000
Decision Date 03/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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