FDA 510(k) Application Details - K133811

Device Classification Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer   More FDA Info for this Device
510(K) Number	K133811
Device Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
Applicant	MAKO SURGICAL CORP. 575 EIGHTH AVE, SUITE 1212 NEW YORK, NY 10018 US Other 510(k) Applications for this Company
Contact	TERRY POWELL Other 510(k) Applications for this Contact
Regulation Number	888.3535   More FDA Info for this Regulation Number
Classification Product Code	NJD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2013
Decision Date	07/08/2014
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