FDA 510(k)

Custom Bars

Número K: K162633 · 2017-07-24

RequerenteImplant Direct Sybron Manufacturing, LLC

Data da decisão2017-07-24

Código do produtoNHA

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Custom Bars is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2017-07-24 under 510(k) number K162633. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Custom Bars?

Custom Bars is a medical device that received FDA 510(k) clearance on 2017-07-24. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K162633.

When did Custom Bars receive FDA 510(k) clearance?

Custom Bars received FDA 510(k) clearance on 2017-07-24, under 510(k) number K162633.

Who is the listed applicant for Custom Bars?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Custom Bars?

The FDA product code for Custom Bars is NHA.

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Fonte oficial

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