ProLink Barb

GUDID 00190837156749

Life Spine, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190837156749
• NIH Device Record Key: f3fea191-e627-4f99-be87-5a6f79ec11e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProLink Barb
• Version Model Number: 129-022
• 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: 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	00190837156749 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231704

FDA Product Code

• OVE: Intervertebral Fusion Device With Integrated Fixation, Cervical

Sterilization

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

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

[00190837156749]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-25
• Device Publish Date: 2024-09-17

On-Brand Devices [ProLink Barb]

• 00190837156725: 129-020
• 00190837156787: 129-026
• 00190837156770: 129-025
• 00190837156763: 129-024
• 00190837156756: 129-023
• 00190837156749: 129-022
• 00190837156732: 129-021