DYNA-LINK 80-3830-0619

GUDID 00190837030285

DYNA-LINK Interbody 38mm x 30mm x 19mm, 6°

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837030285
• NIH Device Record Key: 0b60f1e7-7b6b-47a4-b92c-f24c9b38bc9e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DYNA-LINK
• Version Model Number: 80-3830-0619
• Catalog Number: 80-3830-0619
• 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	00190837030285 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091301

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00190837030285]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2019-11-14

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