FDA 510(k) Application Details - K162641

Device Classification Name	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K162641
Device Name	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Applicant	Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 US Other 510(k) Applications for this Company
Contact	Natalie P. Williams Other 510(k) Applications for this Contact
Regulation Number	888.3310   More FDA Info for this Regulation Number
Classification Product Code	KWZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/22/2016
Decision Date	06/19/2017
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