DEPLOYDatabase

Regulation · Permit

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

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

Jurisdiction: United States · Effective 2026-01-01

Machine-readable surfaces

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.
Methodology: Unreviewed · 1 source (no primary) · last reviewed 2026-08-09

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Architectural position

Cohort: surgical

Sources by quality tier

1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA 510(k) Clearance: Brainlab Spine Mixed Reality Navigation System.

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