Axi+Line Bunion Correction System

GUDID 00817701027065

Axi+Line Instrument Kit

Medartis Inc.

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 00817701027065
• NIH Device Record Key: 56b4c8fe-bd23-4662-a7a9-c621622c9e02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Axi+Line Bunion Correction System
• Version Model Number: AXL-INST
• Company DUNS: 192756786
• Company Name: Medartis 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: true
• Expiration Date: true
• 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	00817701027065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152548

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-11-28
• Device Publish Date: 2020-11-17

On-Brand Devices [Axi+Line Bunion Correction System]

• 00817701028185: Axi-Line Individual Packaged Driver
• 00817701027065: Axi+Line Instrument Kit