Cleared Traditional

NextAR? Spine Platform

K233172 · Medacta International S.A. · Orthopedic
Apr 2024
Decision
209d
Days
Class 2
Risk

About This 510(k) Submission

K233172 is an FDA 510(k) clearance for the NextAR? Spine Platform, a Orthopedic Augmented Reality (Class II — Special Controls, product code SBF), submitted by Medacta International S.A. (Castel San Pietro (Ch), CH). The FDA issued a Cleared decision on April 24, 2024, 209 days after receiving the submission on September 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K233172 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2023
Decision Date April 24, 2024
Days to Decision 209 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.