TiLink-P 20-26100807

GUDID 00856037005088

TiLink-P 26mm x 10mm x 7mm x 8 deg

Tyber Medical LLC

Metal-polymer composite spinal interbody fusion cage

• Primary Device ID: 00856037005088
• NIH Device Record Key: 238cc961-bac5-4f54-bd4c-d93c88ff05dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiLink-P
• Version Model Number: 20-26100807
• Catalog Number: 20-26100807
• 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	00856037005088 [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-P]

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• 00856037005149: TiLink-P 26mm x 10mm x 13mm x 8 deg
• 00856037005132: TiLink-P 26mm x 10mm x 12mm x 8 deg
• 00856037005101: TiLink-P 26mm x 10mm x 9mm x 8 deg
• 00856037005095: TiLink-P 26mm x 10mm x 8mm x 8 deg
• 00856037005088: TiLink-P 26mm x 10mm x 7mm x 8 deg
• 00856037005828: TiLink-P - 26mm x 10mm x 9mm x 0°
• 00856037005811: TiLink-P - 26mm x 10mm x 8mm x 0°
• 00856037005804: TiLink-P - 26mm x 10mm x 12mm x 0°
• 00856037005798: TiLink-P - 26mm x 10mm x 11mm x 0°
• 00856037005781: TiLink-P - 26mm x 10mm x 10mm x 0°