TiLink-T 21-30100513

GUDID 00856037005224

TiLink-T 30mm x 10mm x 13mm x 5 deg

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00856037005224
• NIH Device Record Key: 9d276d17-574a-4fdc-beea-8c229f40f99a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiLink-T
• Version Model Number: 21-30100513
• Catalog Number: 21-30100513
• Company DUNS: 010968002
• Company Name: Tyber Medical LLC
• 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: true
• 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)761-0933
• Email: jstigliano@tybermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856037005224 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130573

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-11-12

On-Brand Devices [TiLink-T]

• 00856037005316: TiLink-T - 34mm x 10mm x 15mm x 5 deg
• 00856037005309: TiLink-T - 34mm x 10mm x 13mm x 5 deg
• 00856037005293: TiLink-T - 34mm x 10mm x 12mm x 5 deg
• 00856037005286: TiLink-T - 34mm x 10mm x 11mm x 5 deg
• 00856037005279: TiLink-T - 34mm x 10mm x 10mm x 5 deg
• 00856037005262: TiLink-T - 34mm x 10mm x 9mm x 5 deg
• 00856037005255: TiLink-T - 34mm x 10mm x 8mm x 5 deg
• 00856037005248: TiLink-T - 34mm x 10mm x 7mm x 5 deg
• 00856037005231: TiLink-T 30mm x 10mm x 15mm x 5 deg
• 00856037005224: TiLink-T 30mm x 10mm x 13mm x 5 deg
• 00856037005217: TiLink-T 30mm x 10mm x 12mm x 5 deg
• 00856037005200: TiLink-T 30mm x 10mm x 11mm x 5 deg
• 00856037005194: TiLink-T 30mm x 10mm x 10mm x 5 deg
• 00856037005187: TiLink-T 30mm x 10mm x 9mm x 5 deg
• 00856037005170: TiLink-T 30mm x 10mm x 8mm x 5 deg
• 00856037005163: TiLink-T 30mm x 10mm x 7mm x 5 deg