Cleared Traditional

xvision Spine system (XVS)

K211188 · Augmedics, Ltd. · Orthopedic
Jul 2021
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K211188 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 July 19, 2021, 90 days after receiving the submission on April 20, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K211188 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2021
Decision Date July 19, 2021
Days to Decision 90 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.