FDA 510(k)

NIDO™ Pedicle Screw System

Número K: K230974 · 2023-09-15

Data da decisão2023-09-15

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

NIDO™ Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Kalitec Medical. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K230974. 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 NIDO™ Pedicle Screw System?

NIDO™ Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Kalitec Medical. The 510(k) number is K230974.

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

NIDO™ Pedicle Screw System received FDA 510(k) clearance on 2023-09-15, under 510(k) number K230974.

Who is the listed applicant for NIDO™ Pedicle Screw System?

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

What is the FDA product code for NIDO™ Pedicle Screw System?

The FDA product code for NIDO™ Pedicle Screw System is NKB.

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