Pro-Link Ti 20-1411-708T

GUDID 00190837031503

Life Spine, Inc.

Metallic spinal fusion cage, non-sterile

• Primary Device ID: 00190837031503
• NIH Device Record Key: 90e4bf9d-f899-4b7a-8a52-bb00ed03d3f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro-Link Ti
• Version Model Number: 20-1411-708T
• Catalog Number: 20-1411-708T
• 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	00190837031503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180642

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

Sterilization

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

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

[00190837031503]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-15
• Device Publish Date: 2019-11-07

On-Brand Devices [Pro-Link Ti]

• 00190837081195: 129-468
• 00190837081188: 129-445
• 00190837081171: 113-887
• 00190837081164: 113-886
• 00190837081157: 113-885
• 00190837081140: 113-884
• 00190837081133: 113-883
• 00190837081126: 113-882
• 00190837081119: 113-881
• 00190837081102: 113-880
• 00190837081096: 113-1722
• 00190837081089: 113-1721
• 00190837081072: 113-1720
• 00190837081065: 113-1719
• 00190837081058: 113-1718
• 00190837081041: 113-1717
• 00190837081034: 113-1716
• 00190837081027: 113-1715
• 00190837081010: 113-1022
• 00190837081003: 113-1021
• 00190837080990: 113-1020
• 00190837080983: 113-1019
• 00190837080976: 113-1018
• 00190837080969: 113-1017
• 00190837080952: 113-1016
• 00190837080945: 113-1015
• 00190837080938: 113-1012
• 00190837080921: 113-1011
• 00190837080914: 113-1010
• 00190837080907: 113-1009
• 00190837080891: 113-1008
• 00190837080884: 113-1007
• 00190837080877: 113-1006
• 00190837080860: 113-1005
• 00190837080853: 129-471
• 00190837080846: 129-460
• 00190837080839: 129-458
• 00190837080822: 129-451
• 00190837080815: 129-393
• 00190837080808: 129-390
• 00190837080792: 129-379
• 00190837080785: 129-377
• 00190837080778: 129-362
• 00190837080761: 129-361
• 00190837080754: 129-360
• 00190837080747: 129-351
• 00190837080730: 113-741
• 00190837080723: 113-1712
• 00190837080716: 113-1711
• 00190837080709: 113-1710