Cleared Traditional

xvision Spine system

K251639 · Augmedics, Ltd. · Orthopedic
Oct 2025
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K251639 is an FDA 510(k) clearance for the xvision Spine system, 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 October 3, 2025, 127 days after receiving the submission on May 29, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K251639 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2025
Decision Date October 03, 2025
Days to Decision 127 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.