FDA 510(k) Application Details - K173717

Device Classification Name	More FDA Info for this Device
510(K) Number	K173717
Device Name	Integra TITAN Reverse Shoulder System
Applicant	Integra LifeSciences Corporation 8700 Cameron Road Suite 100 Austin, TX 78754 US Other 510(k) Applications for this Company
Contact	Kathleen McGuire 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	12/05/2017
Decision Date	06/21/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review