ANTARES Standalone ALIF System

GUDID 00810116510016

ANTARES W40 X D30 X H12 mm, 08° SA ALIF

MIRUS LLC

Metallic spinal interbody fusion cage

• Primary Device ID: 00810116510016
• NIH Device Record Key: 0495b1df-d32a-4f1f-876a-a893df585646
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANTARES Standalone ALIF System
• Version Model Number: 010-L-1208
• Company DUNS: 080311078
• Company Name: MIRUS LLC
• 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	00810116510016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220115

FDA Product Code

• OVD: Intervertebral Fusion Device With Integrated Fixation, Lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-12
• Device Publish Date: 2025-12-04

On-Brand Devices [ANTARES Standalone ALIF System]

• 00810116510160: ANTARES W40 X D30 X H18 mm, 12° SA ALIF
• 00810116510153: ANTARES W40 X D30 X H18 mm, 08° SA ALIF
• 00810116510146: ANTARES W40 X D30 X H16 mm, 25° SA ALIF
• 00810116510139: ANTARES W40 X D30 X H16 mm, 20° SA ALIF
• 00810116510122: ANTARES W40 X D30 X H16 mm, 16° SA ALIF
• 00810116510115: ANTARES W40 X D30 X H16 mm, 12° SA ALIF
• 00810116510108: ANTARES W40 X D30 X H16 mm, 08° SA ALIF
• 00810116510092: ANTARES W40 X D30 X H14 mm, 20° SA ALIF
• 00810116510085: ANTARES W40 X D30 X H14 mm, 16° SA ALIF
• 00810116510078: ANTARES W40 X D30 X H14 mm, 12° SA ALIF
• 00810116510061: ANTARES W40 X D30 X H14 mm, 08° SA ALIF
• 00810116510054: ANTARES W40 X D30 X H13 mm, 16° SA ALIF
• 00810116510047: ANTARES W40 X D30 X H13 mm, 12° SA ALIF
• 00810116510030: ANTARES W40 X D30 X H13 mm, 08° SA ALIF
• 00810116510023: ANTARES W40 X D30 X H12 mm, 12° SA ALIF
• 00810116510016: ANTARES W40 X D30 X H12 mm, 08° SA ALIF
• 00810116510009: ANTARES W40 X D30 X H11 mm, 08° SA ALIF