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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K010594
Device Name DJ ORTHOPEDICS POST SCREW
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
HWC  
Date Received02/28/2001
Decision Date 05/29/2001
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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