Ti Pro-Link Stand-Alone Cervical System

GUDID 00190837017651

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00190837017651
• NIH Device Record Key: 71c95d84-3f0e-4381-899f-8fafabb2dbdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ti Pro-Link Stand-Alone Cervical System
• Version Model Number: 21-1613-05T
• Company DUNS: 183641617
• Company Name: Life Spine, 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: true
• 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	00190837017651 [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

[00190837017651]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-22

On-Brand Devices [Ti Pro-Link Stand-Alone Cervical System]

• 00190837017729: 24-1613-12T
• 00190837017712: 24-1613-11T
• 00190837017705: 24-1613-10T
• 00190837017699: 24-1613-09T
• 00190837017682: 21-1613-08T
• 00190837017675: 21-1613-07T
• 00190837017668: 21-1613-06T
• 00190837017651: 21-1613-05T
• 00190837017644: 23-1613-712T
• 00190837017637: 23-1613-711T
• 00190837017620: 23-1613-710T
• 00190837017613: 23-1613-709T
• 00190837017606: 20-1613-708T
• 00190837017590: 20-1613-707T
• 00190837017583: 20-1613-706T
• 00190837017576: 20-1613-705T
• 00190837066338: Pro-Link 14 x 11 Implant Caddy
• 00190837066321: Pro-Link Screw Driver, Fixed Angle
• 00190837066314: Pro-Link Tap 3.0mm, Fixed Angle
• 00190837066307: Pro-Link Drill 3.0mm, Fixed Angle