FDA 510(k) Application Details - K101996

Device Classification Name	More FDA Info for this Device
510(K) Number	K101996
Device Name	DEPUY GLOBAL UNITE SHOULDER SYSTEM
Applicant	DEPUY (IRELAND) LOUGHBEG RINGASKIDDY CO. CORK IE Other 510(k) Applications for this Company
Contact	RHONDA MYER 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	07/15/2010
Decision Date	12/15/2010
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