FDA 510(k) Application Details - K162256

Device Classification Name	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K162256
Device Name	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Applicant	TOTAL JOINT ORTHOPEDICS, INC. 1567 E. STRATFORD AVENUE SALT LAKE CITY, UT 84106 US Other 510(k) Applications for this Company
Contact	CHRIS WEABER Other 510(k) Applications for this Contact
Regulation Number	888.3565   More FDA Info for this Regulation Number
Classification Product Code	MBH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/11/2016
Decision Date	10/27/2016
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