FDA 510(k)

CarboClear® Cervical Plate System

Número K: K200883 · 2020-06-04

Data da decisão2020-06-04

Código do produtoKWQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CarboClear® Cervical Plate 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 2020-06-04 under 510(k) number K200883. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CarboClear® Cervical Plate System?

CarboClear® Cervical Plate System is a medical device that received FDA 510(k) clearance on 2020-06-04. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K200883.

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

CarboClear® Cervical Plate System received FDA 510(k) clearance on 2020-06-04, under 510(k) number K200883.

Who is the listed applicant for CarboClear® Cervical Plate 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® Cervical Plate System?

The FDA product code for CarboClear® Cervical Plate System is KWQ.

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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 K233989CarboClear® Posterior Cervical Screw System K233944CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments

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Dispositivos Relacionados (Código: KWQ)

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

Fonte oficial

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