FDA 510(k) Application Details - K002796

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented   More FDA Info for this Device
510(K) Number	K002796
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant	STELKAST COMPANY 800 VINIAL ST. #210 PITTSBURGH, PA 15212 US Other 510(k) Applications for this Company
Contact	DONALD A STEVENS 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	09/07/2000
Decision Date	09/28/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review