Mixed Reality Spine Navigation— 510(k) K242569

Substantially Equivalent

Brainlab AG

FDA 510(k) clearance K242569 for Mixed Reality Spine Navigation, Substantially Equivalent on 2025-05-16. Applicant: Brainlab AG. Device class: 2.

Clearance details

Applicant: Brainlab AG
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2024-08-28
Decision date: 2025-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code SBF

K261854 — xvision Spine system2026-07-31
K253805 — Knee+2026-04-24
K252847 — NextAR Hip Platform2026-01-09
K251639 — xvision Spine system2025-10-03
K252054 — SpineAR SNAP (SyncAR Spine)2025-09-29

More clearances from Brainlab AG

K252476 — Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout2025-10-16
K252562 — Spine & Trauma Navigation Instruments2025-09-12
K243432 — Vascular Navigation PAD 2.0; Navigation Software Vascular PAD2025-07-22
K243142 — Cranial 4Pi Immobilization2025-06-23
K250440 — RT Elements (4.5) +11 more2025-06-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.