FDA 510(k) Application Details - K090103

Device Classification Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish   More FDA Info for this Device
510(K) Number	K090103
Device Name	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
Applicant	BIOMET, INC. 56 EAST BELL DR. 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	888.3353   More FDA Info for this Regulation Number
Classification Product Code	MAY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/2009
Decision Date	02/11/2009
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