FDA 510(k)

CarboClear® Posterior Cervical Screw System

Número K: K233989 · 2024-03-27

Data da decisão2024-03-27

Código do produtoNKG

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CarboClear® 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 2024-03-27 under 510(k) number K233989. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CarboClear® Posterior Cervical Screw System?

CarboClear® Posterior Cervical Screw System is a medical device that received FDA 510(k) clearance on 2024-03-27. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K233989.

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

CarboClear® Posterior Cervical Screw System received FDA 510(k) clearance on 2024-03-27, under 510(k) number K233989.

Who is the listed applicant for CarboClear® 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?

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

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Outros registros que listam CarboFix Orthopedics , Ltd. como candidato(a)

K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw System 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 K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments K232341CarboClear® Pedicle Screw System

Ver todos os 25 dispositivos →

Dispositivos Relacionados (Código: NKG)

K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.

Fonte oficial

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