SpineAR SNAP— 510(k) K213034

Substantially Equivalent

Surgical Theater, Inc.

FDA 510(k) clearance K213034 for SpineAR SNAP, Substantially Equivalent on 2022-09-29. 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: 2021-09-21
Decision date: 2022-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pepper Pike, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code SBF

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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.

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

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