Aileron-TRX Expandable Posterior Fusion System

GUDID 00190837000455

Life Spine, Inc.

Interspinous spinal fixation implant

• Primary Device ID: 00190837000455
• NIH Device Record Key: d5524c62-26d0-4e21-937e-dd799e22bad6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aileron-TRX Expandable Posterior Fusion System
• Version Model Number: 132-2314-2
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837000455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100407

FDA Product Code

• PEK: Spinous Process Plate

Sterilization

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

[00190837000455]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-23
• Device Publish Date: 2016-06-06

On-Brand Devices [Aileron-TRX Expandable Posterior Fusion System]

• 00190837000479: 132-2318-2
• 00190837000462: 132-2318-1
• 00190837000455: 132-2314-2
• 00190837000448: 132-2314-1
• 00190837000431: 132-2308-2
• 00190837000424: 132-2308-1