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C-Tek C-Trun Anterior Cervical Plate System

by Interpore Cross Intl. 510(k)

Active United States

510(k) K042798

Overview

The C-Tek C-Thru Anterior Cervical Plate System is a medical device designed for anterior interbody screw fixation of the cervical spine. It is intended for the temporary stabilization of the anterior spine from C2 to C7 during the development of cervical spinal fusions in patients with degenerative disc disease.

This system includes a variety of shapes and sizes of bone plates and screws, offering constrained, semi-constrained, and dynamic construct options. The device is authorized under FDA 510(k) clearance K042798.

AI-generated from registry data, 25 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK042798 Date4 Nov 2004ClearedStatusActive

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 22 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

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Questions

  • What is the intended use of the C-Tek C-Thru Anterior Cervical Plate System?

    This system is designed for the temporary stabilization of the anterior cervical spine, specifically from the C2 to C7 levels. It is indicated for use during the development of cervical spinal fusions in patients diagnosed with degenerative disc disease.

  • What construct options are available with this cervical plate system?

    The system includes a variety of bone plates and screws in different shapes and sizes. It offers surgeons the flexibility to choose between constrained, semi-constrained, and dynamic construct options to suit specific clinical needs.

  • What is the regulatory status of this device?

    The C-Tek C-Thru Anterior Cervical Plate System is authorized under FDA 510(k) clearance K042798. This clearance indicates that the device has been found substantially equivalent to legally marketed predicate devices.