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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 K041389
Device Name SYNTHES CONTOURED SYNMESH SPACER
Applicant
Synthes Spine
1230 Wilson Dr.
West Chester,  PA  19380
Applicant Contact ANGELA MIKROULIS
Correspondent
Synthes Spine
1230 Wilson Dr.
West Chester,  PA  19380
Correspondent Contact ANGELA MIKROULIS
Regulation Number888.3060
Classification Product Code
MQP  
Date Received05/25/2004
Decision Date 10/01/2004
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
Recalls CDRH Recalls
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