Mixed Reality Spine Navigation

GUDID 04056481143985

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 04056481143985
• NIH Device Record Key: 2e50d0b0-2463-4270-8e5f-533fcd2869ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mixed Reality Spine Navigation
• Version Model Number: 1.0
• Company DUNS: 314482980
• Company Name: Brainlab AG
• 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	04056481143985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242569

FDA Product Code

• SBF: Orthopedic Augmented Reality

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-06-09
• Device Publish Date: 2025-05-31

On-Brand Devices [Mixed Reality Spine Navigation]

• 04056481143985: 1.0
• 04056481146672: 1.1