FDA 510(k) Application Details - K211646

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K211646
Device Name	Plate, Fixation, Bone
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	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2021
Decision Date	07/28/2021
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