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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, spinal interlaminal
510(k) Number K091689
Device Name SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM
Applicant
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Applicant Contact STACEY BONNELL
Correspondent
SYNTHES (USA)
1302 WRIGHTS LANE EAST
WEST CHESTER,  PA  19380
Correspondent Contact STACEY BONNELL
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI  
Date Received06/10/2009
Decision Date 07/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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