FDA 510(k) Application Details - K243835

Device Classification Name	More FDA Info for this Device
510(K) Number	K243835
Device Name	TiLink-P SI Joint Fusion System
Applicant	SurGenTec LLC 911 Clint Moore Rd Boca Raton, FL 33487 US Other 510(k) Applications for this Company
Contact	Berny Villejeune Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2024
Decision Date	12/27/2024
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