FDA 510(k) Application Details - K061423

Device Classification Name	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)   More FDA Info for this Device
510(K) Number	K061423
Device Name	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant	BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	BECKY EARL 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	05/23/2006
Decision Date	07/27/2006
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