FDA 510(k) Application Details - K192855

Device Classification Name	More FDA Info for this Device
510(K) Number	K192855
Device Name	DELTA XTEND(TM) Reverse Shoulder System
Applicant	DePuy (Ireland) Loughbeg Ringaskiddy County Cork IE Other 510(k) Applications for this Company
Contact	Ashley Goncalo 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	10/04/2019
Decision Date	02/24/2020
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