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V3 Segmental Plating System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182418

by Atlas Spine, Inc.

Identifiers

510(k) Number
K182418 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 V3 Segmental Plating System is a spinal fixation device classified as an orthopedic implant for segmental stabilization of the cervical spine. It consists of plates and screws designed to provide rigid fixation across multiple vertebral segments, enabling individualized treatment of cervical spine pathologies.

This system is intended for surgical use in spinal orthopedic procedures and is supplied sterile for single-use. It is approved under FDA 510(k) clearance (K182418) and is intended for use in the cervical spine to address complex deformity and degenerative conditions. The device is manufactured by Atlas Spine, Inc., based in Jupiter, Florida.

Frequently asked questions

What types of cervical spine conditions is the V3 Segmental Plating System designed to address in surgical settings?

The V3 Segmental Plating System is specifically designed for surgical use in stabilizing the cervical spine to treat complex deformities and degenerative conditions. It provides rigid fixation across multiple vertebral segments, allowing for individualized treatment of these pathologies.

Is the V3 Segmental Plating System intended for reuse, or is it meant to be used only once?

The V3 Segmental Plating System is supplied sterile and explicitly intended for single-use only. This ensures patient safety and maintains sterility during surgical procedures.

How is the V3 Segmental Plating System regulated in the U.S., and what does that mean for its use?

The V3 Segmental Plating System has received FDA 510(k) clearance under the classification K182418, meaning it has been determined to be substantially equivalent to a legally marketed device. This clearance allows it to be legally marketed and used in the U.S. for its intended purpose in cervical spine stabilization.

What does the system include, and how is it structured for surgical use?

The V3 Segmental Plating System consists of plates and screws designed to provide rigid fixation across multiple cervical spine segments. It is modular and tailored for individualized treatment, enabling surgeons to address specific spinal pathologies with precision.

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: V3 SEGMENTAL PLATE - Atlas Spine, TECHNOLOGIES - Atlas Spine, Atlas Spine Launches V3 Guided Segmental Cervical Plating System ..., Atlas Spine Launched V3 Guided Segmental Cervical Plate

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atlas Spine, Inc.

Sources (1)

  • FDA 510(k) K182418 24 fields · synced Sep 19, 2026