FDA 510(k) Application Details - K243838

Device Classification Name	More FDA Info for this Device
510(K) Number	K243838
Device Name	NEXXT MATRIXX« SI System
Applicant	Nexxt Spine 14425 Bergen Blvd, Suite B Noblesville, IN 46060 US Other 510(k) Applications for this Company
Contact	Andy Elsbury 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	03/14/2025
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