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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name intervertebral fusion device with integrated fixation, cervical
510(k) Number K112068
Device Name SYNTHES ZERO-P VARIABLE ANGLE (VA)
Original Applicant
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester,  PA  19380
Original Contact stacey bonnell
Regulation Number888.3080
Classification Product Code
OVE  
Date Received07/20/2011
Decision Date 11/07/2011
Decision substantially equivalent (SE)
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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