FDA 510(k) Application Details - K082172

Device Classification Name	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K082172
Device Name	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Applicant	MAKO SURGICAL CORPORATION 2555 DAVIE ROAD FORT LAUDERDALE, FL 33317 US Other 510(k) Applications for this Company
Contact	WILLIAM F TAPIA Other 510(k) Applications for this Contact
Regulation Number	888.3520   More FDA Info for this Regulation Number
Classification Product Code	HSX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2008
Decision Date	11/28/2008
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