FDA 510(k) Application Details - K243191

Device Classification Name	More FDA Info for this Device
510(K) Number	K243191
Device Name	Atlas Spine Lateral Expandable Interbody System
Applicant	Atlas Spine, Inc. 1555 Jupiter Park Drive, Suite 1 Jupiter, FL 33458 US Other 510(k) Applications for this Company
Contact	Thomas Smith 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	09/30/2024
Decision Date	11/26/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review