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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 K141314
Device Name SCARLET AC-T SECURED ANTERIOR CERVICAL CAGE AND ASSOCIATED INSTRUMENTATION
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 Number888.3080
Classification Product Code
OVE  
Date Received05/20/2014
Decision Date 09/29/2014
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
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