FDA 510(k) Application Details - K081016

Device Classification Name	More FDA Info for this Device
510(K) Number	K081016
Device Name	SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM
Applicant	SMITH & NEPHEW, INC. 1450 E BROOKS ROAD MEMPHIS, TN 38116 US Other 510(k) Applications for this Company
Contact	JASON SELLS 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	04/09/2008
Decision Date	09/05/2008
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