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PediGuard Threaded

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220160

by SpineGuard.S.A

Identifiers

510(k) Number
K220160 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 Threaded is a neurosurgical drilling instrument designed for precise bone preparation in spinal procedures. Its threaded shaft facilitates controlled insertion and trajectory during anterior spinal surgery, aiding in the secure placement of implants.

Supplied as a reusable device, the PediGuard Threaded is intended for use in operating rooms and minimally invasive surgical settings. It is classified under FDA product code PDQ (Neurosurgical Nerve Locator) and has received FDA 510(k) clearance and MDR authorization. The device is not labeled for MRI use and must be sterilized as per manufacturer guidelines prior to use.

Frequently asked questions

What types of spinal procedures is the PediGuard Threaded designed to assist with, and how does its threaded shaft benefit the surgeon?

The PediGuard Threaded is specifically designed for precise bone preparation during anterior spinal surgery. Its threaded shaft allows for controlled insertion and trajectory, which helps surgeons achieve secure placement of implants by providing stability and reducing slippage during drilling.

Is the PediGuard Threaded reusable, and what sterilization guidelines should be followed before use?

Yes, the PediGuard Threaded is supplied as a reusable device. It must be sterilized according to the manufacturer’s guidelines prior to each use to ensure safety and effectiveness in the operating room or minimally invasive surgical settings.

What regulatory approvals does the PediGuard Threaded hold, and how does this affect its use in clinical settings?

The PediGuard Threaded has received FDA 510(k) clearance and MDR authorization, confirming its compliance with regulatory standards. This means it can be legally marketed and used in the U.S. and EU for its intended purpose—precise bone preparation in spinal procedures—while adhering to established safety and performance requirements.

Can the PediGuard Threaded be used in MRI environments, and if not, what precautions should be taken?

No, the PediGuard Threaded is explicitly not labeled for MRI use. If MRI imaging is required in the same facility, the device must be removed from the patient’s vicinity and stored outside the MRI room to avoid interference or safety risks.

Are there multiple sizes or models of the PediGuard Threaded, and if so, how should a clinician determine the appropriate one for a procedure?

The provided data does not specify distinct sizes or models beyond the core design (threaded shaft for controlled drilling). Selection should be based on the surgeon’s assessment of the patient’s anatomy and the specific surgical requirements, as the device is intended for general anterior spinal bone preparation. Consulting the manufacturer’s guidelines or a surgical specialist is recommended for optimal fit and function.

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, Real Time Sensing DSG Technology, PediGuard, Spine, SpineGuard | Threaded PediGuard to Streamline Surgical Steps, PediGuard Threaded (K220160) — FDA 510 (k) | Innolitics, K220160 FDA 510 (k) - PediGuard Threaded | Spineguard S.A.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

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

Sources (2)

  • FDA 510(k) K220160 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026