Cleared Traditional

xvision Spine system (XVS)

K190929 · Augmedics, Ltd. · Orthopedic

Dec 2019

Decision

255d

Days

Class 2

Risk

About This 510(k) Submission

K190929 is an FDA 510(k) clearance for the xvision Spine system (XVS), a Orthopedic Augmented Reality (Class II — Special Controls, product code SBF), submitted by Augmedics, Ltd. (Yokneam Illit, IL). The FDA issued a Cleared decision on December 20, 2019, 255 days after receiving the submission on April 9, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number	K190929 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 09, 2019
Decision Date	December 20, 2019
Days to Decision	255 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	SBF — Orthopedic Augmented Reality
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.4560
Definition	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.