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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name orthosis, spinal pedicle fixation
510(k) Number K113149
Device Name SYNTHES USS CONNECTORS
Applicant
SYNTHES SPINE
1302 WRIGHTS LN EAST
WEST CHESTER,  PA  19380
Applicant Contact HEATHER GUERIN
Correspondent
SYNTHES SPINE
1302 WRIGHTS LN EAST
WEST CHESTER,  PA  19380
Correspondent Contact HEATHER GUERIN
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   KWQ   MNH   NKB  
Date Received10/24/2011
Decision Date 02/01/2012
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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