FDA 510(k)

Piccolo Composite Proximal Tibia Plate System

N.º K: K201917 · 2020-10-08

Fecha de decisión2020-10-08

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Piccolo Composite Proximal Tibia 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 2020-10-08 under 510(k) number K201917. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Piccolo Composite Proximal Tibia Plate System?

Piccolo Composite Proximal Tibia Plate System is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K201917.

When did Piccolo Composite Proximal Tibia Plate System receive FDA 510(k) clearance?

Piccolo Composite Proximal Tibia Plate System received FDA 510(k) clearance on 2020-10-08, under 510(k) number K201917.

Who is the listed applicant for Piccolo Composite Proximal Tibia 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 Piccolo Composite Proximal Tibia Plate System?

The FDA product code for Piccolo Composite Proximal Tibia Plate System is HRS.

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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

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Fuente oficial

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