FDA 510(k) Application Details - K232986

Device Classification Name	Cerclage, Fixation   More FDA Info for this Device
510(K) Number	K232986
Device Name	Cerclage, Fixation
Applicant	CircumFix Solutions, Inc. 475 East South St. Suite 102 Collierville, TN 38017 US Other 510(k) Applications for this Company
Contact	Ken Richardson 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	09/22/2023
Decision Date	01/30/2024
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