FDA 510(k) Application Details - K050316

Device Classification Name	More FDA Info for this Device
510(K) Number	K050316
Device Name	AEQUALIS REVERSED SHOULDER PROSTHESIS
Applicant	TORNIER 161 RUE LAVOISIER MONTBONNOT, SAINT-ISMIER 38334 FR Other 510(k) Applications for this Company
Contact	Mireille Lemery 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	02/09/2005
Decision Date	03/16/2005
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