FDA 510(k) Application Details - K140071

Device Classification Name	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented   More FDA Info for this Device
510(K) Number	K140071
Device Name	Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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	888.3650   More FDA Info for this Regulation Number
Classification Product Code	KWT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/13/2014
Decision Date	07/28/2014
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