FDA 510(k) Application Details - K203605

Device Classification Name	Component, Traction, Invasive   More FDA Info for this Device
510(K) Number	K203605
Device Name	Component, Traction, Invasive
Applicant	Arbutus Medical Inc. 828 10th Ave W, Suite 560 Vancouver V5Z 1L8 CA Other 510(k) Applications for this Company
Contact	Michael Cancilla Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JEC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2020
Decision Date	04/23/2021
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