FDA 510(k)

Pantheon Spinal Pontus Interbody Fusion Device

Número K: K181548 · 2019-12-16

Data da decisão2019-12-16

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pantheon Spinal Pontus Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Pantheon Spinal. It received FDA 510(k) clearance on 2019-12-16 under 510(k) number K181548. 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 Pantheon Spinal Pontus Interbody Fusion Device?

Pantheon Spinal Pontus Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2019-12-16. The listed applicant is Pantheon Spinal. The 510(k) number is K181548.

When did Pantheon Spinal Pontus Interbody Fusion Device receive FDA 510(k) clearance?

Pantheon Spinal Pontus Interbody Fusion Device received FDA 510(k) clearance on 2019-12-16, under 510(k) number K181548.

Who is the listed applicant for Pantheon Spinal Pontus Interbody Fusion Device?

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

What is the FDA product code for Pantheon Spinal Pontus Interbody Fusion Device?

The FDA product code for Pantheon Spinal Pontus Interbody Fusion Device is MAX.

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Fonte oficial

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