FDA 510(k) Application Details - K151902

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented   More FDA Info for this Device
510(K) Number	K151902
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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	888.3353   More FDA Info for this Regulation Number
Classification Product Code	LZO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2015
Decision Date	09/03/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review