Aileron 132-3-014

GUDID 00190837101695

Interspinous Rasp, 14mm

Life Spine, Inc.

Interspinous spinal fixation implant

• Primary Device ID: 00190837101695
• NIH Device Record Key: ce0ad67d-0a1b-491b-bdc1-4478a8c89e7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aileron
• Version Model Number: 132-3-014
• Catalog Number: 132-3-014
• 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: false
• 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	00190837101695 [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

[00190837101695]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-27
• Device Publish Date: 2019-11-19

On-Brand Devices [Aileron]

• 00190837091507: HEX DRIVER AILERON
• 00190837091491: PUNCH, AILERON, LARGE
• 00190837091484: PUNCH, AILERON, MEDIUM
• 00190837091477: PUNCH, AILERON, SMALL
• 00190837091460: SLEEVE, 18MM
• 00190837091453: SLEEVE, 16MM
• 00190837091439: SLEEVE, 12MM
• 00190837091422: SLEEVE, 10MM
• 00190837091415: SLEEVE, 7MM
• 00190837091408: SLEEVE, 5MM
• 00190837091385: Static Aileron Implant Caddy - Small
• 00190837091347: All-In-One Inserter, Aileron TRX
• 00190837091293: VICE GRIPS
• 00190837043667: Punch, Aileron, Medium
• 00190837043513: Static Aileron Implant Caddy - Small
• 00190837101732: Interspinous Punch 6mm
• 00190837101725: Interspinous Punch 4mm
• 00190837101718: Interspinous Rasp, 18mm
• 00190837101701: Interspinous Rasp, 16mm
• 00190837101695: Interspinous Rasp, 14mm
• 00190837101688: Interspinous Rasp, 12mm
• 00190837101671: Interspinous Rasp, 10mm
• 00190837101664: Interspinous Rasp, 8mm
• 00190837101657: Interspinous Rasp, 6mm
• 00190837101640: Interspinous Rasp, 4mm
• 00190837091446: SLEEVE, 14MM
• 00190837116248: 114-776-4