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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K052746
Device Name CONCORDE VBR SPINAL SYSTEM
Applicant
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact LISA GILMAN
Correspondent
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact LISA GILMAN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received09/30/2005
Decision Date 10/21/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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