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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 K120571
Device Name SYNTHES USS CONNECTOR
Applicant
SYNTHES SPINE
1302 WRIGHTS LN EAST
WEST CHESTER,  PA  19380
Applicant Contact HEMAL MEHTA
Correspondent
SYNTHES SPINE
1302 WRIGHTS LN EAST
WEST CHESTER,  PA  19380
Correspondent Contact HEMAL MEHTA
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   KWQ   MNH   MNI  
Date Received02/27/2012
Decision Date 05/14/2012
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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