FDA 510(k) Application Details - K083827

Device Classification Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K083827
Device Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Applicant	BIOMET MANUFACTURING CORP. PO 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	888.3510   More FDA Info for this Regulation Number
Classification Product Code	KRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2008
Decision Date	02/13/2009
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