FDA 510(k) Application Details - K250603

Device Classification Name	More FDA Info for this Device
510(K) Number	K250603
Device Name	AxTiHA« Stand-Alone ALIF System
Applicant	Innovasis 614 E 3900 S Salt Lake City, UT 84107 US Other 510(k) Applications for this Company
Contact	Mr. Mike Thomas 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	02/28/2025
Decision Date	03/24/2025
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