FDA 510(k)

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

K-Nummer: K254045 · 2026-03-16

AntragstellerCarboFix Orthopedics , Ltd.

Entscheidungsdatum2026-03-16

ProduktcodeNKG

BeratungsausschussOR

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Weitere Einträge mit CarboFix Orthopedics , Ltd. als Antragsteller

K243106CarboClear® Hybrid Pedicle Screw System K233793CarboClear® X Pedicle Screw System K240846CarboClear® 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 Cement K233989CarboClear® Posterior Cervical Screw System K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments K232341CarboClear® Pedicle Screw System

Alle 25 Geräte anzeigen →

Verwandte Geräte (Code: NKG)

K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.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 AG K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K251725ANAX™ OCT WirbelsäulensystemCg Medtech Co., Ltd.

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