FDA 510(k) Application Details - K210890

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K210890
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	G Surgical LLC 9433 Bee Cave Road Building 3, Suite 101-A Austin, TX 78733 US Other 510(k) Applications for this Company
Contact	Donald Grafton Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	ODP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/25/2021
Decision Date	04/23/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review