Devices · Augmedics Ltd.

xvision Spine System

Augmedics Ltd. is listed for xvision Spine System (K241481). The FDA list gives October 16, 2024 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code SBF as “Orthopedic Augmented Reality”: An orthopedic augmented reality device provides visual guidance during orthopedic procedures, where the use of stereotaxic navigation is utilized. Visual guidance is displayed as “augmented reality” stereoscopic images to intraoperatively augment the user’s field of view. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K241481

Official FDA database record

Date of final decision

October 16, 2024

Company on the FDA list

Augmedics Ltd.

Lead panel

Neurology

Primary product code

SBF

openFDA device name for the code

Orthopedic Augmented Reality

Device class

2

Regulation number

882.4560

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary