FDA 510(k) Application Details - K152972

Device Classification Name	More FDA Info for this Device
510(K) Number	K152972
Device Name	Amendia Stand-Alone Cervical System
Applicant	AMENDIA, INC. 1755 WEST OAK PARKWAY MARIETTA, GA 30062 US Other 510(k) Applications for this Company
Contact	KRISTEN ALLEN 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	10/08/2015
Decision Date	01/14/2016
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