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SpineAR SNAP (SyncAR Spine)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K243623

by Surgical Theater, Inc.

Identifiers

510(k) Number
K243623 FDA 510(k)
FDA Product Code
SBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

SpineAR SNAP is an Orthopedic Augmented Reality device, classified as a Class II medical device, designed to provide immersive augmented reality (AR) visualization for spinal surgeries. It leverages AI/ML-powered vertebra segmentation to transform 2D medical imaging (such as MRI and CT scans) into interactive 3D models, enabling enhanced pre-operative planning and real-time intra-operative guidance for spinal implant procedures.

The device is supplied as a software-based system and is intended for use in sterile operating room environments during spinal stereotaxic surgeries. It is classified under FDA regulation 21 CFR 882.4560 and holds a 510(k) clearance with the designation Special under the Neurology advisory committee. SpineAR SNAP is not labeled as single-use or reusable, and its MRI safety has not been explicitly stated in the provided data.

Frequently asked questions

How is SpineAR SNAP intended to be used during spinal surgeries, and what type of imaging does it work with?

SpineAR SNAP is designed for use in sterile operating rooms during spinal stereotaxic surgeries to provide immersive augmented reality visualization. It transforms 2D medical imaging—such as MRI and CT scans—into interactive 3D models using AI/ML-powered vertebra segmentation. This enables enhanced pre-operative planning and real-time intra-operative guidance for spinal implant procedures.

Is SpineAR SNAP a single-use or reusable device, and what are its storage requirements?

The device is not explicitly labeled as single-use or reusable in the provided data. Since it is a software-based system intended for sterile operating room environments, it should be handled in accordance with standard sterile field protocols. Storage requirements are not detailed, but it should be stored in a clean, controlled environment to maintain system integrity and prevent contamination.

What regulatory pathway did SpineAR SNAP follow for FDA clearance, and what classification does it hold?

SpineAR SNAP is classified as a Class II medical device under FDA regulation 21 CFR 882.4560. It received a 510(k) clearance with the designation 'Special' under the Neurology advisory committee, specifically the Orthopedic Review Panel (OR). The clearance was granted as substantially equivalent to a predicate device.

Does SpineAR SNAP have any specific compatibility or safety considerations for use in MRI environments?

The provided data does not explicitly state whether SpineAR SNAP is MRI-safe. If MRI compatibility is required for your workflow, you should verify this directly with Surgical Theater, Inc. as it may impact how the device is used in conjunction with MRI equipment.

What types of spinal procedures is SpineAR SNAP primarily intended to assist with?

While the device is designed for spinal stereotaxic surgeries, its primary function is to enhance visualization and guidance for spinal implant procedures by converting 2D imaging (MRI/CT) into interactive 3D models. It is not labeled for any specific clinical indication but is intended to support pre-operative planning and intra-operative navigation during these procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SyncAR Spine: Transforming Spinal Surgery with XR Technology, SpineAR SNAP (SyncAR Spine) Review: Pricing, FDA Status & Alternatives ..., SpineAR SNAP (SyncAR Spine) | FDA Radiology AI Device

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Surgical Theater, Inc.

Sources (1)

  • FDA 510(k) K243623 24 fields · synced Sep 19, 2026