FDA 510(k)

Preference Elite Pedicle Screw System

Número K: K162160 · 2016-11-18

Data da decisão2016-11-18

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Preference Elite Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Amedica Corporation. It received FDA 510(k) clearance on 2016-11-18 under 510(k) number K162160. 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 Preference Elite Pedicle Screw System?

Preference Elite Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-11-18. The listed applicant is Amedica Corporation. The 510(k) number is K162160.

When did Preference Elite Pedicle Screw System receive FDA 510(k) clearance?

Preference Elite Pedicle Screw System received FDA 510(k) clearance on 2016-11-18, under 510(k) number K162160.

Who is the listed applicant for Preference Elite Pedicle Screw System?

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

What is the FDA product code for Preference Elite Pedicle Screw System?

The FDA product code for Preference Elite Pedicle Screw System is NKB.

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