Pro-Link 114-103-4

GUDID 00190837089474

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837089474
• NIH Device Record Key: 042f463f-0b61-4e6e-a13a-ac829b8c264f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro-Link
• Version Model Number: 114-103-4
• Catalog Number: 114-103-4
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837089474 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160066

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[00190837089474]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-11-07

On-Brand Devices [Pro-Link]

• 00190837089474: 114-103-4
• 00190837081928: 112-205