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CarboClear® Posterior Cervical Screw System - CarboClear® Posterior Cervical Screw System

by Carbofix Orthopedics Ltd

510(k) K254045

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK254045 Date16 Mar 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NKG
Models / Variants
CarboClear® Posterior Cervical Screw System
FDA applicant
CarboFix Orthopedics , Ltd.
Device Class
Class II
Regulation
21 CFR Part 888.3075
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CarboClear Posterior Cervical Screw System and CarboClear Hybrid Posterior Cervical Screw System are spinal implants designed to restore the integrity of the spinal column. They are intended for use in patients with advanced stage tumors involving the cervical spine where life expectancy is insufficient to permit the achievement of fusion.

These systems are authorized under FDA 510k clearance K254045. The devices are manufactured by CarboFix Orthopedics Ltd, located in Herzeliya, Israel.

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of the CarboClear Posterior Cervical Screw System?

    The CarboClear Posterior Cervical Screw System and Hybrid System are spinal implants engineered to restore the integrity of the spinal column in patients diagnosed with advanced stage tumors of the cervical spine.

  • Which patient population is this system designed for?

    These systems are specifically indicated for patients with advanced stage cervical spine tumors where the patient's life expectancy is not sufficient to allow for the achievement of spinal fusion.

  • What is the regulatory status of these spinal implants?

    The CarboClear Posterior Cervical Screw System and the CarboClear Hybrid Posterior Cervical Screw System are authorized under FDA 510k clearance number K254045.