FDA 510(k)

Piccolo Composite® Plate System

N.º K: K182015 · 2018-10-11

Fecha de decisión2018-10-11

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Piccolo Composite® 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 2018-10-11 under 510(k) number K182015. 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® Plate System?

Piccolo Composite® Plate System is a medical device that received FDA 510(k) clearance on 2018-10-11. The listed applicant is CarboFix Orthopedics , Ltd.. The 510(k) number is K182015.

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

Piccolo Composite® Plate System received FDA 510(k) clearance on 2018-10-11, under 510(k) number K182015.

Who is the listed applicant for Piccolo Composite® 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® Plate System?

The FDA product code for Piccolo Composite® 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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