FDA 510(k) Application Details - K163669

Device Classification Name	More FDA Info for this Device
510(K) Number	K163669
Device Name	Humeris Shoulder
Applicant	Fx Solutions 1663 Rue de Majornas Viriat 01440 FR Other 510(k) Applications for this Company
Contact	Jean-Jacques Martin 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	12/27/2016
Decision Date	05/17/2017
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