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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
Recalls CDRH Recalls
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