DynaLink 125-707

GUDID 00190837104580

Modular Distractor Tip Right

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837104580
• NIH Device Record Key: 340b1742-75b8-4279-b43f-5b9dfdbf2aef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaLink
• Version Model Number: 125-707
• Catalog Number: 125-707
• 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: false
• 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	00190837104580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180215

FDA Product Code

• OVD: Intervertebral fusion device with integrated fixation, lumbar

Sterilization

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

[00190837104580]

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: 2019-11-19

On-Brand Devices [DynaLink]

• 00190837104627: 3.5mm Ball End Hex Driver
• 00190837104610: Barb Caddy
• 00190837104603: Screw Caddy
• 00190837104580: Modular Distractor Tip Right
• 00190837104573: Modular Distractor Tip Left
• 00190837104566: Fixed Angle Awl
• 00190837104559: 4mm Hex Driver