FDA 510(k) Application Details - K240368

Device Classification Name	More FDA Info for this Device
510(K) Number	K240368
Device Name	E3DÖ-A Interbody System
Applicant	Evolution Spine 2300 N. Haskell Ave Dallas, TX 75204 US Other 510(k) Applications for this Company
Contact	Todd Wallenstein 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	02/06/2024
Decision Date	05/15/2024
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