Aileron TRX

GUDID 00190837137106

Life Spine, Inc.

Interspinous spinal fixation implant

• Primary Device ID: 00190837137106
• NIH Device Record Key: 03c6f738-207b-4727-9ef7-32b4a7ecc41b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aileron TRX
• Version Model Number: 132-2314-2
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837137106 [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

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

[00190837137106]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-01
• Device Publish Date: 2022-01-24

On-Brand Devices [Aileron TRX]

• 00190837137106: 132-2314-2
• 00190837137090: 132-2308-2