FDA 510(k) Application Details - K243116

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K243116
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Integrity Implants Inc. dba Accelus 354 Hiatt Drive Palm Beach Gardens, FL 33418 US Other 510(k) Applications for this Company
Contact	Lauren Kamer 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	09/30/2024
Decision Date	05/21/2025
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