Dyna-Link Elite

GUDID 00190837020828

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837020828
• NIH Device Record Key: 7da6eff4-17f2-4c10-8340-b511bd0c2687
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dyna-Link Elite
• Version Model Number: 81-160-25
• Company DUNS: 183641617
• Company Name: Life Spine, Inc.
• Device Count: 1
• DM Exempt: true
• 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	00190837020828 [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

[00190837020828]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2017-05-24

On-Brand Devices [Dyna-Link Elite]

• 00190837021009: 81-3828-1217
• 00190837020996: 81-3828-1215
• 00190837020989: 81-3828-1213
• 00190837020972: 81-3828-1211
• 00190837020965: 81-3828-0617
• 00190837020958: 81-3828-0615
• 00190837020941: 81-3828-0613
• 00190837020934: 81-3828-0611
• 00190837020927: 81-3424-1217
• 00190837020910: 81-3424-1215
• 00190837020903: 81-3424-1213
• 00190837020897: 81-3424-1211
• 00190837020880: 81-3424-0617
• 00190837020873: 81-3424-0615
• 00190837020866: 81-3424-0613
• 00190837020859: 81-3424-0611
• 00190837020842: 81-160-30
• 00190837020835: 81-160-27
• 00190837020828: 81-160-25
• 00190837020811: 81-160-22
• 00190837020804: 81-160-20
• 00190837020798: 81-155-30
• 00190837020781: 81-155-27
• 00190837020774: 81-155-25
• 00190837020767: 81-155-22
• 00190837020750: 81-155-20
• 00190837071240: Dyna-Link, 42mmx30mmx17mm, 12 Degree
• 00190837071233: Dyna-Link, 34mmx24mmx13mm, 12 Degree
• 00190837034696: Dyna-Link Elite Graft Packing Plate, 38x28