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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 K072434
Device Name SYNTHES OC FUSION AND SYNAPSE SYSTEMS
Applicant
SYNTHES SPINE CO.LP
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact SUSAN LEWANDOWSKI
Correspondent
SYNTHES SPINE CO.LP
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact SUSAN LEWANDOWSKI
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received08/29/2007
Decision Date 01/10/2008
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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