FDA 510(k) Application Details - K212307

Device Classification Name	Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K212307
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	Nadine Adia 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	07/23/2021
Decision Date	10/12/2021
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