Juliet® OL Lumbar Interbody Device JUL-OL 28 12-S

GUDID 07640139345097

Straight Transforaminal Lumbar Cage

SpineArt SA

Polymeric spinal fusion cage, sterile

• Primary Device ID: 07640139345097
• NIH Device Record Key: 64d43574-8fae-4217-8f2d-fbaac0dc95c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Juliet® OL Lumbar Interbody Device
• Version Model Number: JUL-OL 28 12-S
• Catalog Number: JUL-OL 28 12-S
• 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: true
• 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: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter
• Height: 12 Millimeter
• Length: 28 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640139345097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101720

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-18
• Device Publish Date: 2015-10-16

On-Brand Devices [Juliet® OL Lumbar Interbody Device]

• 07640139345301: Straight Transforaminal Lumbar Cage
• 07640139345295: Straight Transforaminal Lumbar Cage
• 07640139345288: Straight Transforaminal Lumbar Cage
• 07640139345264: Straight Transforaminal Lumbar Cage
• 07640139345257: Straight Transforaminal Lumbar Cage
• 07640139345240: Straight Transforaminal Lumbar Cage
• 07640139345141: Straight Transforaminal Lumbar Cage
• 07640139345134: Straight Transforaminal Lumbar Cage
• 07640139345127: Straight Transforaminal Lumbar Cage
• 07640139345103: Straight Transforaminal Lumbar Cage
• 07640139345097: Straight Transforaminal Lumbar Cage
• 07640139345080: Straight Transforaminal Lumbar Cage