SpineAR SNAP (SyncAR Spine)— 510(k) K243623

Name: FDA 510(k) clearance K243623
Creator: U.S. Food and Drug Administration
Published: 2024-12-24

Substantially Equivalent

Surgical Theater, Inc.

FDA 510(k) clearance K243623 for SpineAR SNAP (SyncAR Spine), Substantially Equivalent on 2024-12-24. 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: 2024-11-25
Decision date: 2024-12-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Beachwood, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SBF

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K261854 — xvision Spine system2026-07-31
K253805 — Knee+2026-04-24
K252847 — NextAR Hip Platform2026-01-09
K251639 — xvision Spine system2025-10-03
K252054 — SpineAR SNAP (SyncAR Spine)2025-09-29

More clearances from Surgical Theater, Inc.

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K213034 — SpineAR SNAP2022-09-29
K201465 — SuRgical Planner (SRP) BrainStorm2020-07-17

Recalls naming K243623

K-number listed on FDA's recall record

Z-0324-2026 — SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented realityClass II·Ongoing·Surgical Theater Inc·20250916

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K243623.

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