FDA 510(k)

CarboClear Navigated Instruments

N.º K: K201251 · 2020-08-05

Fecha de decisión2020-08-05

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

CarboClear Navigated Instruments 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 2020-08-05 under 510(k) number K201251. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CarboClear Navigated Instruments?

CarboClear Navigated Instruments is a medical device that received FDA 510(k) clearance on 2020-08-05. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K201251.

When did CarboClear Navigated Instruments receive FDA 510(k) clearance?

CarboClear Navigated Instruments received FDA 510(k) clearance on 2020-08-05, under 510(k) number K201251.

Who is the listed applicant for CarboClear Navigated Instruments?

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 Navigated Instruments?

The FDA product code for CarboClear Navigated Instruments is OLO.

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Otros registros que enlistan a CarboFix Orthopedics , Ltd. como solicitante

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 los 25 dispositivos →

Dispositivos relacionados (Código: OLO)

K262506Remex Spine Surgery Navigation - Universal InstrumentsRemex Medical Corp.K261410Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral Registration Kit))Suite 201, National Innovation Centre K261205SPINEART Navigation Instrument SystemSpineart SA K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.K262121Ion-L Navigated InstrumentsSurGenTec, LLC K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.