FDA 510(k) Application Details - K203531

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K203531
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Aegis Spine, Inc. 9781 S. Meridian Blvd, Ste 300 Englewood, CO 80112 US Other 510(k) Applications for this Company
Contact	Woo Joong Kwon 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	12/02/2020
Decision Date	01/29/2021
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