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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 bone graft, cervical
510(k) Number K122366
Device Name TRYPTIK CC ANTERIOR INTERSOMATIC CERVICAL CAGE
Original Applicant
SPINEART
cointrin 20 route de pre-bois
cp1813
geneva,  SZ 1215
Original Contact frank pennesi
Regulation Number888.3080
Classification Product Code
ODP  
Date Received08/06/2012
Decision Date 10/04/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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