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FDA 510(k)

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System

K-Number: K254045 · 2026-03-16

ApplicantCarboFix Orthopedics , Ltd.
Decision Date2026-03-16
Product CodeNKG
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System is the device name listed in this FDA 510(k) record. The listed applicant is CarboFix Orthopedics , Ltd.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K254045. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System?

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K254045.

When did CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System receive FDA 510(k) clearance?

CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System received FDA 510(k) clearance on 2026-03-16, under 510(k) number K254045.

Who is the listed applicant for CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System?

The FDA 510(k) record lists CarboFix Orthopedics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System?

The FDA product code for CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System is NKG.

Other records listing CarboFix Orthopedics , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243106CarboClear® Hybrid Pedicle Screw SystemK233793CarboClear® X Pedicle Screw SystemK240846CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone CementK233989CarboClear® Posterior Cervical Screw SystemK233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated InstrumentsK232341CarboClear® Pedicle Screw System

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Related Devices (Code: NKG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AGK253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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