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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
Applicant
SPINEART
COINTRIN 20 ROUTE DE PRE-BOIS
CP1813
GENEVA,  CH 1215
Applicant Contact FRANK PENNESI
Correspondent
SPINEART
COINTRIN 20 ROUTE DE PRE-BOIS
CP1813
GENEVA,  CH 1215
Correspondent Contact FRANK PENNESI
Regulation Number888.3080
Classification Product Code
ODP  
Date Received08/06/2012
Decision Date 10/04/2012
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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