FDA 510(k) Application Details - K152754

Device Classification Name	More FDA Info for this Device
510(K) Number	K152754
Device Name	COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)
Applicant	BIOMET MANUFACTURING CORP. 56 BELL DRIVE WARSAW, IN 46580 US Other 510(k) Applications for this Company
Contact	PATRICIA SANDBORN BERES Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2015
Decision Date	05/16/2016
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