Cleared Special

SpineAR SNAP (SyncAR Spine)

K243623 · Surgical Theater, Inc. · Orthopedic
Dec 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K243623 is an FDA 510(k) clearance for the SpineAR SNAP (SyncAR Spine), a Orthopedic Augmented Reality (Class II — Special Controls, product code SBF), submitted by Surgical Theater, Inc. (Beachwood, US). The FDA issued a Cleared decision on December 24, 2024, 29 days after receiving the submission on November 25, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 882.4560.

Submission Details

510(k) Number K243623 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 2024
Decision Date December 24, 2024
Days to Decision 29 days
Submission Type Special
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.