Plateau-P Spacer System

GUDID 00190837011758

Life Spine, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: 00190837011758
• NIH Device Record Key: c5bb0e1f-6af6-4e2a-9c13-830f08b9a26b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plateau-P Spacer System
• Version Model Number: 53-1127-12
• 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	00190837011758 [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

[00190837011758]

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: 2016-06-09

On-Brand Devices [Plateau-P Spacer System]

• 00190837011772: 53-1127-14
• 00190837011765: 53-1127-13
• 00190837011758: 53-1127-12
• 00190837011741: 53-1127-11
• 00190837011734: 53-1127-10
• 00190837011727: 53-1127-09
• 00190837011710: 53-1127-08