FDA 510(k)

Talos® Lumbar (HA) PEEK IBF Devices

Número K: K170395 · 2017-06-02

Data da decisão2017-06-02

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Talos® Lumbar (HA) PEEK IBF Devices is the device name listed in this FDA 510(k) record. The listed applicant is Meditech Spine, LLC. It received FDA 510(k) clearance on 2017-06-02 under 510(k) number K170395. 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 Talos® Lumbar (HA) PEEK IBF Devices?

Talos® Lumbar (HA) PEEK IBF Devices is a medical device that received FDA 510(k) clearance on 2017-06-02. The listed applicant is Meditech Spine, LLC. The 510(k) number is K170395.

When did Talos® Lumbar (HA) PEEK IBF Devices receive FDA 510(k) clearance?

Talos® Lumbar (HA) PEEK IBF Devices received FDA 510(k) clearance on 2017-06-02, under 510(k) number K170395.

Who is the listed applicant for Talos® Lumbar (HA) PEEK IBF Devices?

The FDA 510(k) record lists Meditech Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Talos® Lumbar (HA) PEEK IBF Devices?

The FDA product code for Talos® Lumbar (HA) PEEK IBF Devices is MAX.

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Fonte oficial

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