FDA 510(k) Application Details - K250072

Device Classification Name	More FDA Info for this Device
510(K) Number	K250072
Device Name	CONDUITÖ SYNFIXÖ Evolution Secured Spacer System
Applicant	Avalign Technologies, Inc. 8727 Clinton Park Drive Fort Wayne, IN 46825 US Other 510(k) Applications for this Company
Contact	Jennifer Staunton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/10/2025
Decision Date	07/10/2025
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