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FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System

[in effect]

United States · permit · permit

All Policies

Jurisdiction

United States

Classification

permit

Status

in effect

Effective Date

Jan 1, 2026

Primary Sources

1 audited

Statutory Scope & Summary

FDA cleared the Brainlab Spine Mixed Reality Navigation system for US launch, providing augmented reality-based surgical navigation for spinal procedures.

Covered Sectors & Application Domains

Service & Cobot Robotics/

Regulatory Analysis & Inquiries

6 entries
What does FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System cover?

FDA cleared the Brainlab Spine Mixed Reality Navigation system for US launch, providing augmented reality-based surgical navigation for spinal procedures.

Where does FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System apply?

FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System is recorded as a permitting requirement applying in United States on the DEPLOY registry.

When did FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System take effect?

FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System is recorded as effective January 1, 2026 on the DEPLOY registry.

Is FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System still in effect?

FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System is currently in effect and applies to covered operators in the named jurisdiction.

What types of robots does FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System apply to?

FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System is recorded as applying to surgical on the DEPLOY registry.

Which robot models on the DEPLOY registry fall under FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System?

8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System: ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.

Primary Sources & Legal Instruments

1 document
  • https://www.brainlab.com/press-releases-landingpage/brainlab-announces-fda-510-k-clearance-and-us-launch-of-spine-mixed-reality-navigation/

    https://www.brainlab.com/press-releases-landingpage/brainlab-announces-fda-510-k-clearance-and-us-launch-of-spine-mixed-reality-navigation/

    Official Source