Skip to content

Mixed Reality Spine Navigation

by Brainlab AG

510(k) K242569

Mixed Reality Spine Navigation is a Class II device made by Brainlab AG, cleared under FDA 510(k) K242569 on 16 May 2025, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242569 Date16 May 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
SBF
Device class
Class II
Regulation
21 CFR Part 882.4560
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K242569

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K242569
UDI-DISize and differences
Mixed Reality Spine Navigation 1.0
Brainlab SE
1.004056481143985 —No longer on the market
Mixed Reality Spine Navigation 1.1
Brainlab SE
1.104056481146672 —On the market

Other devices from Brainlab AG

  • Automatic Registration

    Class II

  • RT Elements (4.0)

    Class II

  • ENT Em

    Class II

  • Z-Touch

    Class II

See all devices from Brainlab AG →