FDA 510(k) Application Details - K220765

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K220765
Device Name	Cerclage, Fixation
Applicant	Riverpoint Medical, LLC 815 NE 25th Ave Portland, OR 97232 US Other 510(k) Applications for this Company
Contact	Edwin Anderson Other 510(k) Applications for this Contact
Regulation Number	888.3010   More FDA Info for this Regulation Number
Classification Product Code	JDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2022
Decision Date	07/26/2023
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