FDA 510(k) Application Details - K210167

Device Classification Name	More FDA Info for this Device
510(K) Number	K210167
Device Name	DELTA XTEND Reverse Shoulder System
Applicant	DePuy Orthopaedics Inc. 700 Orthopaedic Drive Warsaw, IN 46582 US Other 510(k) Applications for this Company
Contact	Megan Bernier 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	01/21/2021
Decision Date	02/19/2021
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