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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 K994187
Device Name SYNTHES CERVIFIX SYSTEM
Applicant
SYNTHES (USA)
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI,  PA  19301
Applicant Contact JONATHAN GILBERT
Correspondent
SYNTHES (USA)
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI,  PA  19301
Correspondent Contact JONATHAN GILBERT
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNI  
Date Received12/13/1999
Decision Date 12/21/1999
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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