FDA 510(k)

CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System

Número K: K201926 · 2020-08-07

Data da decisão2020-08-07

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CarboClear® Pedicle Screw System, CarboClear® II Pedicle 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 2020-08-07 under 510(k) number K201926. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System?

CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2020-08-07. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K201926.

When did CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System receive FDA 510(k) clearance?

CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System received FDA 510(k) clearance on 2020-08-07, under 510(k) number K201926.

Who is the listed applicant for CarboClear® Pedicle Screw System, CarboClear® II Pedicle 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® Pedicle Screw System, CarboClear® II Pedicle Screw System?

The FDA product code for CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System is NKB.

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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

Ver todos os 25 dispositivos →

Dispositivos Relacionados (Código: NKB)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Fonte oficial

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