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xvision Spine System

by Augmedics Ltd 4 variants

510(k) K241481

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 NumberK241481 Date16 Oct 2024ClearedStatusActive

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  • Withdrawn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
FDA applicant
Augmedics, Ltd.
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

Cited by

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

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The xvision Spine System is an Orthopedic Augmented Reality device designed to enhance surgical visualization during spine procedures. It integrates augmented reality technology to overlay anatomical structures, enabling surgeons to navigate instruments and implants with greater precision and accuracy. By providing real-time, three-dimensional imaging, it supports complex interventions such as spinal fusion, decompression, and instrumentation placement.

This system is intended for use in operating rooms during spine surgeries and is supplied as a reusable, non-sterile device. It requires calibration and integration with compatible surgical tools and imaging systems. The xvision Spine System is classified under FDA device class II (SBF) and holds a Traditional 510(k) clearance with the advisory committee designation for Neurology. It is regulated under FDA regulation number 882.4560 and is not intended for MRI use.

Devices cleared under K241481

7 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 K241481
UDI-DISize and differences
BNC to BNC Cable ACC00418
AUGMEDICS LTD.
ACC0041807290113781078
Prescription: no; Single use: no
On the market
C-arm Ring Adaptor AMCH07610
AUGMEDICS LTD.
AMCH0761007290113781054
Prescription: yes; Single use: no
On the market
DVI-I to BNC Adaptor ACC00417
AUGMEDICS LTD.
ACC0041707290113781085
Prescription: no; Single use: no
On the market
HDMI to HDMI cable ACC00416
AUGMEDICS LTD.
ACC0041607290113781108
Prescription: no; Single use: no
On the market
VGA to HDMI adaptor ACC00415
AUGMEDICS LTD.
ACC0041507290113781092
Prescription: no; Single use: no
On the market
XVS MARKERS FOR ASC KIT 3 SETS PACK ASP07056
AUGMEDICS LTD.
ASP0705617290113781037
Prescription: yes; Single use: yes
On the market
XVS MARKERS WITH C-LINK KIT 10 SETS PACK ASP07059
AUGMEDICS LTD.
ASP0705917290113781044
Prescription: yes; Single use: yes
On the market

Similar devices

Other devices filed under FDA product code SBF (Orthopedic Augmented Reality).

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