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Disposable Pedicle Screw Probe, Model 3603-00

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K063729

by Technomed Europe

Identifiers

510(k) Number
K063729 FDA 510(k)
FDA Product Code
GXZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.1350 FDA 510(k)
Regulation Number
882.1350 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Disposable Pedicle Screw Probe, Model 3603-00, is a single-use electrode and needle designed for neurological applications. It is intended for use in procedures involving pedicle screw fixation, where precise placement and electrical stimulation or monitoring may be required.

This device is supplied sterile and intended for single-use only. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and MDD authorization. The probe is intended for use in sterile surgical environments and must be handled according to standard aseptic techniques. No MRI safety information is specified.

Frequently asked questions

What is the primary purpose of the Disposable Pedicle Screw Probe, Model 3603-00, in surgical procedures?

The Disposable Pedicle Screw Probe, Model 3603-00, is designed for use in pedicle screw fixation procedures, particularly in neurological applications. It serves as both an electrode and a needle to facilitate precise placement of pedicle screws while enabling electrical stimulation or monitoring during surgery.

Is this device intended for reuse, or is it meant to be used only once?

This device is explicitly intended for single-use only. The manufacturer emphasizes that it is supplied sterile and must be handled as a disposable item to maintain aseptic conditions in sterile surgical environments.

How should the Disposable Pedicle Screw Probe be stored before use?

While specific storage instructions aren’t detailed in the provided data, the probe is supplied sterile and must be kept in a sealed, uncontaminated package until use. Standard sterile medical device storage practices—such as avoiding exposure to moisture, extreme temperatures, or direct light—should be followed to preserve sterility.

What regulatory pathways has this device undergone, and which committees were involved?

The Disposable Pedicle Screw Probe, Model 3603-00, has received FDA 510(k) clearance under the Traditional pathway, with a decision described as *Substantially Equivalent* to a predicate device. It was reviewed by the Neurology (NE) Advisory Committee and authorized under the MDD (Medical Device Directive) in the EU. The submission was filed in 2006 and cleared in 2007.

Can this probe be used in MRI environments, or are there any safety concerns?

The provided data does not specify MRI safety information for this probe. If MRI compatibility is required, additional verification from the manufacturer or independent testing would be necessary to ensure safe use in magnetic resonance imaging environments.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Technomed Europe

Sources (2)

  • FDA 510(k) K063729 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026