Cleared Traditional

K252054 - SpineAR SNAP (SyncAR Spine) (FDA 510(k) Clearance)

K252054 · Surgical Theater, Inc. · Orthopedic device
Sep 2025
Decision
90d
Days
Class 2
Risk

K252054 is an FDA 510(k) clearance for the SpineAR SNAP (SyncAR Spine). This device is classified as 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 September 29, 2025, 90 days after receiving the submission on July 1, 2025.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 882.4560. 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..

Submission Details

510(k) Number K252054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2025
Decision Date September 29, 2025
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.