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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 K080568
Device Name X-MESH EXPANDABLE CAGE SYSTEM
Applicant
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact HANDE TUFAN
Correspondent
DEPUY SPINE, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact HANDE TUFAN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received02/29/2008
Decision Date 05/01/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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