FLXfit 15

GUDID M725AT40100

FLXfit 15 Expandable Interbody

CORELINK LLC

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

Primary Device ID	M725AT40100
NIH Device Record Key	3d1e70b5-8c3e-4d70-9042-6f6cd4765f3f
Commercial Distribution Status	In Commercial Distribution
Brand Name	FLXfit 15
Version Model Number	AT4010
Company DUNS	064191453
Company Name	CORELINK LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Unsafe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M725AT40100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K171519

FDA Product Code

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar