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Cervical Plate System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K223753

by Double Medical Technology Inc.

Identifiers

510(k) Number
K223753 FDA 510(k)
FDA Product Code
KWQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3060 FDA 510(k)
Regulation Number
888.3060 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cervical Plate System is a spinal fixation device classified as an Anterior Cervical Plate (Device Type: KWQ) under orthopedic nomenclature. It is designed for internal fixation of the cervical spine, providing stability to segments from C2 to C7. The system is intended for surgical applications in conditions such as degenerative disc disease, trauma, tumors, deformities, pseudarthrosis, or revision surgeries following failed fusions. Its construction ensures multi-planar stability through a three-screw plate configuration, enhancing structural integrity during spinal stabilization procedures.

This system is supplied sterile and intended for single-use in surgical settings. It is regulated under FDA 510(k) clearance (K223753) as substantially equivalent to predicate devices, with approval for orthopedic applications. The system includes modular components such as plates and cages, with specific sizing tailored for cervical spine anatomy. Storage requires adherence to sterile packaging protocols, and MRI safety considerations must be evaluated per manufacturer guidelines. No additional regulatory markings beyond the stated 510(k) clearance are provided in the specifications.

Frequently asked questions

What conditions is the Cervical Plate System designed to treat?

The Cervical Plate System is intended for surgical stabilization of the cervical spine in conditions such as degenerative disc disease, trauma, tumors, deformities, pseudarthrosis, or revision surgeries following failed fusions. Its three-screw plate configuration provides multi-planar stability to segments from C2 to C7, ensuring structural integrity during spinal procedures.

How is the Cervical Plate System supplied and intended for use?

The system is supplied sterile and is designed for single-use in surgical settings only. This ensures compliance with sterile protocols and minimizes the risk of infection or contamination during spinal fixation procedures.

What modular components are included in the Cervical Plate System?

The system includes modular components such as plates and cages, with specific sizing tailored to cervical spine anatomy. This modularity allows for customization to fit individual patient anatomy and surgical requirements.

How should the Cervical Plate System be stored?

Storage must adhere strictly to the sterile packaging protocols provided by the manufacturer. This ensures the device remains uncontaminated and ready for surgical use when needed.

Are there any special considerations for MRI safety with this device?

MRI safety must be evaluated per manufacturer guidelines before use. While the specifications do not explicitly state MRI compatibility, clinicians should consult the provided documentation to ensure safe imaging practices post-implantation.

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: Products - Double Medical Technology, Spine - Double Medical Technology Inc., Anterior Cervical Spine Plate III System - Double Medical Technology ..., Anterior Cervical Spine Plate Ⅳ - Double Medical Technology

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Double Medical Technology Inc.
FDA Applicant
Double Medical Technology, Inc.

Sources (1)

  • FDA 510(k) K223753 24 fields · synced Oct 1, 2026