SpineAR SNAP (SyncAR Spine)— 510(k) K252054

Name: FDA 510(k) clearance K252054
Creator: U.S. Food and Drug Administration
Published: 2025-09-29

Substantially Equivalent

Surgical Theater, Inc.

FDA 510(k) clearance K252054 for SpineAR SNAP (SyncAR Spine), Substantially Equivalent on 2025-09-29. Applicant: Surgical Theater, Inc.. Device class: 2.

Clearance details

Applicant: Surgical Theater, Inc.
Product code: Code SBF
Device class: Class 2
Regulation: 21 CFR 882.4560
Advisory panel: Neurology
Date received: 2025-07-01
Decision date: 2025-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beachwood, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Surgical Theater, Inc.

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K243623 — SpineAR SNAP (SyncAR Spine)2024-12-24
K213034 — SpineAR SNAP2022-09-29
K201465 — SuRgical Planner (SRP) BrainStorm2020-07-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.