FDA 510(k)

OrthoPediatrics Locking Proximal Femur System Cortical Screws

N.º K: K162307 · 2016-09-27

Fecha de decisión2016-09-27

Código de productoHRS

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

OrthoPediatrics Locking Proximal Femur System Cortical Screws is the device name listed in this FDA 510(k) record. The listed applicant is OrthoPediatrics Corp.. It received FDA 510(k) clearance on 2016-09-27 under 510(k) number K162307. 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 OrthoPediatrics Locking Proximal Femur System Cortical Screws?

OrthoPediatrics Locking Proximal Femur System Cortical Screws is a medical device that received FDA 510(k) clearance on 2016-09-27. The listed applicant is OrthoPediatrics Corp.. The 510(k) number is K162307.

When did OrthoPediatrics Locking Proximal Femur System Cortical Screws receive FDA 510(k) clearance?

OrthoPediatrics Locking Proximal Femur System Cortical Screws received FDA 510(k) clearance on 2016-09-27, under 510(k) number K162307.

Who is the listed applicant for OrthoPediatrics Locking Proximal Femur System Cortical Screws?

The FDA 510(k) record lists OrthoPediatrics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoPediatrics Locking Proximal Femur System Cortical Screws?

The FDA product code for OrthoPediatrics Locking Proximal Femur System Cortical Screws is HRS.

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Fuente oficial

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