FDA 510(k) Application Details - K962034

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K962034
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant	ARTOS MEDICAL PRODUCTS GMBH CASTLEWAY DRIVE WEST,SUITE 236 INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	DOUGLAS W STUART Other 510(k) Applications for this Contact
Regulation Number	888.3360   More FDA Info for this Regulation Number
Classification Product Code	LWJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/1996
Decision Date	10/23/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review