FDA 510(k) Application Details - K111635

Device Classification Name	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K111635
Device Name	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Applicant	SMITH & NEPHEW, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 US Other 510(k) Applications for this Company
Contact	MEGAN BEVILL 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	06/13/2011
Decision Date	09/09/2011
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