_Regulation · Permit_

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

Canonical ID: `3b1d3ebb-ccbf-4503-b8aa-91dd70a4091b`

- **Jurisdiction:** [United States](/locations/united-states.md) (id: `aa8b9c05-c836-4021-801f-59801970401e`)
- **Kind:** `permit`
- **Status (derived):** in_effect
- **Effective:** 2026-01-01

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

## Sources (1)

1. https://www.brainlab.com/press-releases-landingpage/brainlab-announces-fda-510-k-clearance-and-us-launch-of-spine-mixed-reality-navigation/ · 2026-01-01

## Status history

- **in_effect** · 2026-01-01 · agent-recon
    - Initial ingestion

## Common questions

### 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.


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