FDA 510(k)

Libra Pedicle Screw System

Número K: K162750 · 2016-10-27

Data da decisão2016-10-27

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Libra Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Balance, Inc.. It received FDA 510(k) clearance on 2016-10-27 under 510(k) number K162750. 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 Libra Pedicle Screw System?

Libra Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2016-10-27. The listed applicant is Spinal Balance, Inc.. The 510(k) number is K162750.

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

Libra Pedicle Screw System received FDA 510(k) clearance on 2016-10-27, under 510(k) number K162750.

Who is the listed applicant for Libra Pedicle Screw System?

The FDA 510(k) record lists Spinal Balance, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Dispositivos Relacionados (Código: NKB)

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