FDA 510(k) Application Details - K152622

Device Classification Name	More FDA Info for this Device
510(K) Number	K152622
Device Name	Alta ACDF System
Applicant	BIOMET SPINE 310 INTERLOCKEN PARKWAY, SUITE 120 BROOMFIELD, CO 80021 US Other 510(k) Applications for this Company
Contact	ALEXANDRA BECK 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	09/14/2015
Decision Date	07/08/2016
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