FDA 510(k) Application Details - K141314

Device Classification Name	More FDA Info for this Device
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 15 1215 CH Other 510(k) Applications for this Company
Contact	Franck Pennesi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2014
Decision Date	09/29/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review