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SpineGuard DSG Zavation Screw System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K162884

by SpineGuard.S.A

Identifiers

510(k) Number
K162884 FDA 510(k)
FDA Product Code
HBG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4300 FDA 510(k)
Regulation Number
882.4300 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SpineGuard DSG Zavation Screw System is a manual drill, burr, trephine, and accessory device designed for spinal surgery. It provides real-time impedance feedback during pedicle screw insertion to assist surgeons in identifying potential soft tissue contact or cortical perforation at the screw tip.

This system is intended for use with the Zavation Spinal System and requires additional components, including the SpineGuard DSG Threaded Drill System. It is classified as a Class II medical device under FDA regulations (21 CFR 882.4300) and holds a 510(k) clearance (K162884) for substantial equivalence in the neurology specialty. The device is not described as single-use or reusable in the available data.

Frequently asked questions

What is the primary purpose of the SpineGuard DSG Zavation Screw System in spinal surgery?

The SpineGuard DSG Zavation Screw System is designed to assist surgeons during pedicle screw insertion by providing real-time impedance feedback. This feature helps identify potential soft tissue contact or cortical perforation at the screw tip, improving precision and safety during spinal procedures.

Is the SpineGuard DSG Zavation Screw System compatible with other spinal systems, and what additional components are required?

Yes, the SpineGuard DSG Zavation Screw System is specifically intended for use with the Zavation Spinal System. It requires additional components, including the SpineGuard DSG Threaded Drill System, to function properly.

How is the SpineGuard DSG Zavation Screw System classified under FDA regulations, and what clearance does it hold?

The SpineGuard DSG Zavation Screw System is classified as a Class II medical device under FDA regulations (21 CFR 882.4300). It holds a 510(k) clearance (K162884) for substantial equivalence in the neurology specialty, demonstrating it meets FDA requirements for safety and effectiveness.

What types of tools are included in the SpineGuard DSG Zavation Screw System, and how does it differ from standard manual drills?

The SpineGuard DSG Zavation Screw System combines a manual drill, burr, trephine, and associated accessories into one device. Unlike standard manual drills, it includes real-time impedance feedback technology, which helps surgeons detect potential complications like soft tissue contact or cortical perforation during pedicle screw insertion, enhancing procedural safety.

Is there any information provided about whether the SpineGuard DSG Zavation Screw System is single-use or reusable?

The available data does not explicitly state whether the SpineGuard DSG Zavation Screw System is intended for single-use or reuse. This would need to be confirmed through manufacturer guidelines or additional documentation, as it is not specified in the provided details.

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 Instruction For Use of the DSG® Zavation Screw System, SpineGuard DSG Zavation Screw System (K162884) — FDA 510 (k ..., PDF DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and ...

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) K162884 24 fields · synced Sep 18, 2026