FDA 510(k) Application Details - K240066

Device Classification Name	More FDA Info for this Device
510(K) Number	K240066
Device Name	Fine OsteotomyÖ
Applicant	Bodycad Laboratories Inc. 2035 rue du Haut-Bord Quebec G1N 4R7 CA Other 510(k) Applications for this Company
Contact	Nadine Adia Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/09/2024
Decision Date	02/09/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review