Juliet® OL Transforaminal Lumbar Cage JUL-OL 28 08-N

GUDID 07640139345233

Straight Transforaminal Lumbar Cage

SpineArt SA

Polymeric spinal interbody fusion cage

Primary Device ID	07640139345233
NIH Device Record Key	897ebca9-180d-450e-817d-c2a736237d95
Commercial Distribution Status	In Commercial Distribution
Brand Name	Juliet® OL Transforaminal Lumbar Cage
Version Model Number	JUL-OL 28 08-N
Catalog Number	JUL-OL 28 08-N
Company DUNS	483016148
Company Name	SpineArt SA
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 Dimensions

Height	8 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter
Length	28 Millimeter
Height	8 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640139345233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K101720

FDA Product Code

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar