xvision Spine system (XVS)— 510(k) K211188

Substantially Equivalent

Augmedics, Ltd.

FDA 510(k) clearance K211188 for xvision Spine system (XVS), Substantially Equivalent on 2021-07-19. 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: 2021-04-20
Decision date: 2021-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam Illit, IL

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 Augmedics, Ltd.

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

Recalls naming K211188

K-number listed on FDA's recall record

Z-1761-2025 — Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-assisted spinal surgery.Class II·Ongoing·Augmedics Ltd.·20250414

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K211188.

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