FDA 510(k) Application Details - K061253

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous   More FDA Info for this Device
510(K) Number	K061253
Device Name	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Applicant	SMITH & NEPHEW, INC. 1450 BROOKS RD. MEMPHIS, TN 38116 US Other 510(k) Applications for this Company
Contact	KATIE LOGEROT Other 510(k) Applications for this Contact
Regulation Number	888.3358   More FDA Info for this Regulation Number
Classification Product Code	MBL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2006
Decision Date	05/31/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review