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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 K984377
Device Name SYNTHES SPINE CERVIFIX SYSTEM
Applicant
SYNTHES (USA)
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI,  PA  19301
Applicant Contact JONATHAN M GILBERT
Correspondent
SYNTHES (USA)
P.O. BOX 0548
1690 RUSSELL ROAD
PAOLI,  PA  19301
Correspondent Contact JONATHAN M GILBERT
Regulation Number888.3050
Classification Product Code
KWP  
Date Received12/03/1998
Decision Date 01/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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