FDA 510(k) Application Details - K040354

Device Classification Name	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)   More FDA Info for this Device
510(K) Number	K040354
Device Name	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant	ENCORE MEDICAL, L.P. 9800 METRIC BLVD. AUSTIN, TX 78758 US Other 510(k) Applications for this Company
Contact	DEBBIE DE LOS SANTOS 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	02/12/2004
Decision Date	11/04/2004
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