FDA 510(k) Application Details - K161520

Device Classification Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K161520
Device Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Applicant	Onkos Surgical, Inc. 77 East Halsey Road Parsippany, NJ 07054 US Other 510(k) Applications for this Company
Contact	Jan Triani 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	06/02/2016
Decision Date	10/28/2016
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