FDA 510(k) Application Details - K132285

Device Classification Name	More FDA Info for this Device
510(K) Number	K132285
Device Name	AEQUALIS REVERSED SHOULDER PROSTHESIS
Applicant	TORNIER, SAS 161. RUE LAVOISIER MONTBONNOT SAINT MARTIN 38330 FR Other 510(k) Applications for this Company
Contact	MAGALIE HENNEQUIN 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	07/23/2013
Decision Date	12/05/2013
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