FDA 510(k) Application Details - K190588

Device Classification Name	More FDA Info for this Device
510(K) Number	K190588
Device Name	Integra TITAN Reverse Shoulder System
Applicant	Integra LifeSciences Corporation 11101 Metric Blvd Austin, TX 78758 US Other 510(k) Applications for this Company
Contact	Blesson Abraham 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	03/07/2019
Decision Date	12/02/2019
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