PediGuard Nerve Detector System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123390 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 PediGuard Nerve Detector System is a neurosurgical nerve locator designed to assist in the identification and evaluation of spinal nerves during surgical procedures. It employs low-voltage electrical stimulation and electromyographic (EMG) monitoring to detect nerve responses in real time, enhancing precision during spinal implant placement or nerve-related interventions.
This system is intended for intraoperative use in sterile surgical environments and is classified as a Class II medical device under FDA regulations. It is supplied as a reusable device and is not intended for direct contact with the central nervous system. The system operates without radiation and requires appropriate training for safe and effective application, adhering to regulatory standards including FDA 510(k) clearance and MDR compliance.
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: PDF SpineGuard, S.A. ℅ John Smith, M.D., J.D. Partner Hogan Lovells US LLP, Instruction For Use of the Threaded PediGuard - SpineGuard, A handheld fiber-optic tissue sensing device for spine surgery - PMC, Toward automatic bone breach detection for spine surgery ... - HAL
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K123390 | Class II | Active |
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Manufacturer
- Manufacturer
- SpineGuard.S.A
- FDA Applicant
- Spineguard S.A.
Sources (2)
- FDA 510(k) K123390 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 28, 2026