FDA 510(k) Application Details - K131231

Device Classification Name	More FDA Info for this Device
510(K) Number	K131231
Device Name	AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESIS
Applicant	Tornier SAS 161 RUE LAVOISIER MONTBONNOT SAINT MARTIN 38330 FR Other 510(k) Applications for this Company
Contact	SEVERINE BONNETON 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	04/30/2013
Decision Date	10/16/2013
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