xvision Spine system— 510(k) K261854

Substantially Equivalent

Augmedics, Ltd.

FDA 510(k) clearance K261854 for xvision Spine system, Substantially Equivalent on 2026-07-31. Applicant: Augmedics, Ltd.. Device class: 2.

Clearance details

Applicant: Augmedics, Ltd.
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2026-06-03
Decision date: 2026-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Illit, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code SBF

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
K252530 — OptiVu Shoulder2025-09-10

More clearances from Augmedics, Ltd.

K250255 — xvision Spine system2025-03-13
K241481 — xvision Spine System2024-10-16
K220905 — xvision Spine System2022-11-17
K211188 — xvision Spine system (XVS)2021-07-19
K190929 — xvision Spine system (XVS)2019-12-20

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