FDA 510(k)

Elaris Pedicle Screw System

Número K: K183091 · 2019-08-02

Data da decisão2019-08-02

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Elaris Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Spinewelding AG. It received FDA 510(k) clearance on 2019-08-02 under 510(k) number K183091. 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 Elaris Pedicle Screw System?

Elaris Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2019-08-02. The listed applicant is Spinewelding AG. The 510(k) number is K183091.

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

Elaris Pedicle Screw System received FDA 510(k) clearance on 2019-08-02, under 510(k) number K183091.

Who is the listed applicant for Elaris Pedicle Screw System?

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

What is the FDA product code for Elaris Pedicle Screw System?

The FDA product code for Elaris Pedicle Screw System is NKB.

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