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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 K003043
Device Name SURGICAL TITANIUM MESH SYSTEM
Applicant
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact KAREN F JURCZAK
Correspondent
Depuyacromed
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact KAREN F JURCZAK
Regulation Number888.3060
Classification Product Code
MQP  
Date Received09/29/2000
Decision Date 05/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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