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PreView-III Anterior Cervical Plate System

by Nexus Spine, LLC 510(k)

Active United States

510(k) K223627

Overview

The PreView-III Anterior Cervical Plate System is a spinal fixation orthosis used to immobilize the cervical spine during fusion procedures. The system consists of metal plates with preassembled locking rings and bone screws.

It is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway. The device is supplied by Nexus Spine, LLC and has received FDA 510(k) clearance under K223627.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK223627 Date2 Feb 2023ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Nexus Spine, LLC.

See all devices from Nexus Spine, LLC. →

Questions

  • What is the PreView-III Anterior Cervical Plate System used for?

    The PreView-III Anterior Cervical Plate System is a spinal fixation orthosis designed to immobilize the cervical spine during fusion procedures. It provides stability by securing metal plates with preassembled locking rings and bone screws to the vertebral bodies, supporting bone graft healing and preventing motion at the operated levels.

  • How is the PreView-III Anterior Cervical Plate System supplied and is it sterile or reusable?

    The system is supplied by Nexus Spine, LLC as a set of metal plates with preassembled locking rings and bone screws. While the device data does not explicitly state sterility or single-use status, as a Class 2 implantable orthopedic device cleared via 510(k), it is intended for single surgical use and is typically provided in a sterile condition to prevent infection during implantation.

  • What regulatory pathway was used for the PreView-III Anterior Cervical Plate System and what is its product code?

    The PreView-III Anterior Cervical Plate System was cleared through the FDA's Traditional 510(k) pathway under submission number K223627. It is classified as a Class 2 orthopedic device with product code KWQ, which corresponds to spinal fixation devices, and was determined to be substantially equivalent to a predicate device.