FDA 510(k) Application Details - K112615

Device Classification Name	More FDA Info for this Device
510(K) Number	K112615
Device Name	AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
Applicant	TORNIER, INC. 7701 FRANCE AVE SOUTH SUITE 600 EDINA, MN 55435 US Other 510(k) Applications for this Company
Contact	BRAHIM HADRI 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	09/08/2011
Decision Date	10/11/2011
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