FDA 510(k) Application Details - K221535

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K221535
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Acuity Surgical Devices, LLC 8710 N. Royal Lane Irving, TX 75063 US Other 510(k) Applications for this Company
Contact	Bryan Cowan Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/2022
Decision Date	07/22/2022
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