FDA 510(k) Application Details - K081059

Device Classification Name	More FDA Info for this Device
510(K) Number	K081059
Device Name	AEQUALIS REVERSED SHOULDER PROSTHESIS
Applicant	TORNIER 161 RUE LAVOISIER MONTBONNOT, SAINT-ISMIER 38334 FR Other 510(k) Applications for this Company
Contact	DAMIEN GUILLAUD 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	04/14/2008
Decision Date	07/17/2008
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