E-LIFT®

GUDID 00190361039365

ELIFT Inserter

SPINEFRONTIER, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190361039365
• NIH Device Record Key: 1b7f8cc0-9046-43e0-a6c7-9704bbf02e24
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: E-LIFT®
• Version Model Number: 11-06103
• Company DUNS: 002003243
• Company Name: SPINEFRONTIER, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: +1(866)914-7717
• Email: customerservice@spinefrontier.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190361039365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111553

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190361039365]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-10-05

On-Brand Devices [E-LIFT®]

• 00190361039365: ELIFT Inserter
• 00190361002345: E-LIFT, Coned, 9W X 30L X 14H
• 00190361002338: E-LIFT, Coned, 9W X 30L X 13H
• 00190361002321: E-LIFT, Coned, 9W X 30L X 12H
• 00190361002314: E-LIFT, Coned, 9W X 30L X 11H
• 00190361002307: E-LIFT, Coned, 9W X 30L X 10H
• 00190361002291: E-LIFT, Coned, 9W X 30L X 9H
• 00190361002284: E-LIFT, Coned, 9W X 30L X 8H
• 00190361002277: E-LIFT, Coned, 8W X 24L X 14H
• 00190361002260: E-LIFT, Coned, 8W X 24L X 13H
• 00190361002253: E-LIFT, Coned, 8W X 24L X 12H
• 00190361002246: E-LIFT, Coned, 8W X 24L X 11H
• 00190361002239: E-LIFT, Coned, 8W X 24L X 10H
• 00190361002222: E-LIFT, Coned, 8W X 24L X 9H
• 00190361002215: E-LIFT, Coned, 8W X 24L X 8H