FDA 510(k) Application Details - K162068

Device Classification Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K162068
Device Name	Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Applicant	Fournitures Hospitalieres Industrie ZI de Kernevez û 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	888.3670   More FDA Info for this Regulation Number
Classification Product Code	MBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/26/2016
Decision Date	04/10/2017
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