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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 K053508
Device Name SYNFIX-LR
Applicant
SYNTHES SPINE CO.LP
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact ANGELA MIKROULIS
Correspondent
SYNTHES SPINE CO.LP
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact ANGELA MIKROULIS
Regulation Number888.3060
Classification Product Code
MQP  
Date Received12/16/2005
Decision Date 02/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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