FDA 510(k) Application Details - K181302

Device Classification Name	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K181302
Device Name	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Applicant	Bodycad Laboratories Inc. 2035, rue du Haut-Bord Quebec City G1N 4R7 CA Other 510(k) Applications for this Company
Contact	Marc Chaunet 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	05/17/2018
Decision Date	01/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review