Dyna-Link

GUDID 00190837078607

Life Spine, Inc.

Metallic spinal interbody fusion cage

• Primary Device ID: 00190837078607
• NIH Device Record Key: edde38d3-f312-46f7-9c0c-c7870957f12f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dyna-Link
• Version Model Number: 85-655-25
• 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	00190837078607 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191834

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

[00190837078607]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-16
• Device Publish Date: 2021-04-08

On-Brand Devices [Dyna-Link]

• 00190837081935: 112-210
• 00190837030292: DYNA-LINK Interbody 38mm x 30mm x 19mm, 12°
• 00190837030285: DYNA-LINK Interbody 38mm x 30mm x 19mm, 6°
• 00190837078607: 85-655-25
• 00190837078652: 85-666-25