Alignment Software Spine

GUDID 04056481146320

The Alignment Software Spine is intended to support the surgeon in reaching a predefined position through semi-automated alignment of surgical instruments based on information obtained from optical tracking devices.

Brainlab AG

Electromagnetic/optical surgical navigation device tracking system

• Primary Device ID: 04056481146320
• NIH Device Record Key: 8898d4ad-ff88-4f3e-a857-200e27094699
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alignment Software Spine
• Version Model Number: 2.1
• 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	04056481146320 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221618

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

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: 2025-06-24
• Device Publish Date: 2025-06-16

On-Brand Devices [Alignment Software Spine]

• 04056481144470: The Alignment Software Spine supports the surgeon in reaching a pre-defined position by controll
• 04056481146320: The Alignment Software Spine is intended to support the surgeon in reaching a predefined positio