Aileron Expandable Posterior Fusion System

GUDID 00190837000028

Life Spine, Inc.

Interspinous spinal fixation implant

• Primary Device ID: 00190837000028
• NIH Device Record Key: e84d4d03-5084-44af-a9b6-caa95fd67c39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aileron Expandable Posterior Fusion System
• Version Model Number: 132-308-2
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190837000028 [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

[00190837000028]

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 Expandable Posterior Fusion System]

• 00190837000134: 132-111
• 00190837000127: 132-338-2
• 00190837000110: 132-338-1
• 00190837000103: 132-334-2
• 00190837000097: 132-334-1
• 00190837000080: 132-328-2
• 00190837000073: 132-328-1
• 00190837000066: 132-318-2
• 00190837000059: 132-318-1
• 00190837000042: 132-314-2
• 00190837000035: 132-314-1
• 00190837000028: 132-308-2
• 00190837000011: 132-308-1
• 00190837000004: 132-108