FDA 510(k) Application Details - K113271

Device Classification Name	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)   More FDA Info for this Device
510(K) Number	K113271
Device Name	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant	BIOMET MANUFACTURING, INC. 56 EAST BELL DR. P.O BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	GARY BAKER 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	11/04/2011
Decision Date	05/18/2012
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