Plateau Spacer Sysytem 54-1024-715

GUDID 00190837018771

10mm x 24mm x 15mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837018771
• NIH Device Record Key: 17fa53ab-3ce0-4647-91fd-1123f9da8fd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau Spacer Sysytem
• Version Model Number: 54-1024-715
• Catalog Number: 54-1024-715
• 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	00190837018771 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111569

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00190837018771]

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: 2019-11-07

On-Brand Devices [Plateau Spacer Sysytem]

• 00190837018788: 10mm x 24mm x 16mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted
• 00190837018771: 10mm x 24mm x 15mm Titanium PLATEAU Interbody, 7° , Straight, Bulleted