Anterior Cervical IBFD EX AC4-141610-07

GUDID B084AC4141610070

KEOS

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage

Primary Device ID	B084AC4141610070
NIH Device Record Key	8678ff8d-478a-498d-ad33-b62ae8dabe5a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Anterior Cervical IBFD EX
Version Model Number	14D x 16W x 10H x 7L, PEEK-HA
Catalog Number	AC4-141610-07
Company DUNS	080551837
Company Name	KEOS
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
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	B084AC4141610070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K212450

FDA Product Code

ODP	Intervertebral Fusion Device With Bone Graft, Cervical