FDA 510(k) Application Details - K991538

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented   More FDA Info for this Device
510(K) Number	K991538
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant	SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. MEMPHIS, TN 38116 US Other 510(k) Applications for this Company
Contact	JANET JOHNSON GREEN Other 510(k) Applications for this Contact
Regulation Number	888.3350   More FDA Info for this Regulation Number
Classification Product Code	JDI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/03/1999
Decision Date	06/03/1999
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