Juliet® OL Lumbar Interbody Device JUL-OL 28 10-N

GUDID 07640139345240

Straight Transforaminal Lumbar Cage

SpineArt SA

Polymeric spinal interbody fusion cage

Primary Device ID	07640139345240
NIH Device Record Key	7d1012fa-2e08-43ae-94bb-cb48d60b9c23
Commercial Distribution Status	In Commercial Distribution
Brand Name	Juliet® OL Lumbar Interbody Device
Version Model Number	JUL-OL 28 10-N
Catalog Number	JUL-OL 28 10-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	10 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 Millimeter
Length	28 Millimeter
Height	10 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	07640139345240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K101720

FDA Product Code

MAX	Intervertebral Fusion Device With Bone Graft, Lumbar