FDA 510(k) Application Details - K242483

Device Classification Name	More FDA Info for this Device
510(K) Number	K242483
Device Name	Genesys Spine AIS-C II Cervical Interbody Fusion System
Applicant	Genesys Spine 1250 South Capital of Texas Highway Building 3, Suite 600 Austin, TX 78746 US Other 510(k) Applications for this Company
Contact	Derek Southard Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/21/2024
Decision Date	02/07/2025
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