FDA 510(k) Application Details - K961378

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K961378
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant	ZIMMER, INC. P.O. BOX 708 WARSAW, IN 46581-0708 US Other 510(k) Applications for this Company
Contact	KAREN CAIN 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	04/10/1996
Decision Date	10/08/1996
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