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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K153042
Device Name TRYPTIK2C-plate Anterior Cervical Plate System
Applicant
SPINEART
INTERNATIONAL CENTER COINTRIN
20 ROUTE DE PRE-BOIS, CP1813
GENEVA,  CH 1215
Applicant Contact Franck PENNESI
Correspondent
SPINEART
INTERNATIONAL CENTER COINTRIN
20 ROUTE DE PRE-BOIS, CP1813
GENEVA,  CH 1215
Correspondent Contact Franck PENNESI
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received10/19/2015
Decision Date 03/28/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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