FDA 510(k)

Dispositivos revestidos com Ti-Bond da Spinal Elements

Número K: K181837 · 2018-11-02

Data da decisão2018-11-02

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spinal Elements Ti-Bond coated devices is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K181837. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Spinal Elements Ti-Bond coated devices?

Spinal Elements Ti-Bond coated devices is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K181837.

When did Spinal Elements Ti-Bond coated devices receive FDA 510(k) clearance?

Spinal Elements Ti-Bond coated devices received FDA 510(k) clearance on 2018-11-02, under 510(k) number K181837.

Who is the listed applicant for Spinal Elements Ti-Bond coated devices?

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

What is the FDA product code for Spinal Elements Ti-Bond coated devices?

The FDA product code for Spinal Elements Ti-Bond coated devices is MAX.

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Fonte oficial

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