FDA 510(k) Application Details - K143543

Device Classification Name	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K143543
Device Name	Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
Applicant	BIOMET INC. 56 EAST BELL DRIVE WARSAW, IN 46581 US Other 510(k) Applications for this Company
Contact	JARED COOPER Other 510(k) Applications for this Contact
Regulation Number	888.3540   More FDA Info for this Regulation Number
Classification Product Code	KRR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2014
Decision Date	01/30/2015
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