FDA 510(k) Application Details - K003523

Device Classification Name	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)   More FDA Info for this Device
510(K) Number	K003523
Device Name	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant	DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 WARSAW, IN 46581-0988 US Other 510(k) Applications for this Company
Contact	LYNNETTE WHITAKER Other 510(k) Applications for this Contact
Regulation Number	888.3330   More FDA Info for this Regulation Number
Classification Product Code	KWA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2000
Decision Date	12/13/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review