FDA 510(k) Application Details - K001471

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K001471
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant	IMPLEX CORP. 80 COMMERCE DR. ALLENDALE, NJ 07401-1600 US Other 510(k) Applications for this Company
Contact	JOHN A SCHALAGO 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	05/11/2000
Decision Date	08/07/2000
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