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DSG Connect Technology

FDA 510(k)

Class II (US FDA 510(k))

510(k) K201454

by SpineGuard.S.A

Identifiers

510(k) Number
K201454 FDA 510(k)
FDA Product Code
PDQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.1820 FDA 510(k)
Regulation Number
874.1820 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The DSG Connect Technology is a neurosurgical nerve locator designed to assist in identifying neural structures during spinal procedures. It provides real-time feedback to help surgeons detect changes in electrical conductivity, indicating potential contact with soft tissues during pedicle drilling.

This device is used in open or minimally invasive spinal fusion procedures and is supplied as a reusable system. It includes a probe and an app for visualizing audio feedback, ensuring MRI safety as indicated by its regulatory classification. Authorized under FDA 510(k) clearance (K201454), it adheres to regulatory standards for Class II medical devices (regulation number 874.1820) and is intended for use in Ear, Nose, and Throat specialties.

Frequently asked questions

How is the DSG Connect Technology used during spinal procedures, and what type of feedback does it provide?

The DSG Connect Technology is designed to assist surgeons during open or minimally invasive spinal fusion procedures by identifying neural structures. It works by providing real-time feedback through electrical conductivity changes, alerting the surgeon to potential contact with soft tissues during pedicle drilling. This helps minimize the risk of nerve damage by giving audible and visual cues via an accompanying app.

Is the DSG Connect Technology reusable, and what components make up the system?

Yes, the DSG Connect Technology is supplied as a reusable system. It consists of a probe and an app for visualizing audio feedback, allowing surgeons to monitor neural structures safely during spinal procedures.

Can this device be used safely in MRI environments, and why is that important?

Yes, the DSG Connect Technology is explicitly indicated as MRI-safe, which is critical for procedures where patients may require MRI follow-ups. This ensures the device won’t interfere with imaging or pose risks during scans, making it suitable for use in hybrid surgical settings.

What regulatory pathway was followed for FDA clearance of the DSG Connect Technology, and what classification does it hold?

The DSG Connect Technology received FDA clearance through a traditional 510(k) review process (K201454) and is classified as a Class II medical device under regulation number 874.1820. This classification reflects its role as a neurosurgical nerve locator, which requires stringent validation for safety and effectiveness in detecting neural structures during spinal 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: SpineGuard | The DSG Connect App to Visualize Your Drilling, PDF SpineGuard, S.A. ℅ John Smith, M.D., J.D. Partner Hogan Lovells US LLP, K201454 - DSG Connect Technology | FDA 510(k) | Spineguard S.A., K201454 - DSG Connect Technology FDA 510 (k) APPLICATION FOR SpineGuard ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
SpineGuard.S.A
FDA Applicant
Spineguard S.A.

Sources (1)

  • FDA 510(k) K201454 24 fields · synced Sep 18, 2026