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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name thoracolumbosacral pedicle screw system
510(k) Number K052151
Device Name SYNTHES PANGEA MONOAXIAL SYSTEM
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 Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received08/08/2005
Decision Date 12/07/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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