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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 K121852
Device Name SYNTHES ZERO-P VARIABLE ANGLE (VA)
Original Applicant
SYNTHES SPINE CO.LP
1302 wrights lane east
west chester,  PA  19380
Original Contact monika mcdole-russell
Regulation Number888.3080
Classification Product Code
OVE  
Date Received06/25/2012
Decision Date 07/25/2012
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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