FDA 510(k) Application Details - K112193

Device Classification Name	More FDA Info for this Device
510(K) Number	K112193
Device Name	ARROW REVERSE SHOULDER SYSTEM
Applicant	FOURNITURES HOSPITALIERES INDUSTRIE ZI DE KERNEVEZ-6 RUE NOBEL QUIMPER 29000 FR Other 510(k) Applications for this Company
Contact	PATRICIA DONNARD 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	07/29/2011
Decision Date	07/12/2012
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