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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name posterior metal/polymer spinal system, fusion
510(k) Number K073347
Device Name DYNESYS TOP-LOADING SPINAL SYSTEM
Original Applicant
ZIMMER SPINE, INC
7375 bush lake rd.
minneapolis,  MN  55439 2027
Original Contact elsa a linke
Regulation Number888.3070
Classification Product Code
NQP  
Date Received11/29/2007
Decision Date 02/08/2008
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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