FDA 510(k)

Rampart A Lumbar Interbody Fusion Device

Número K: K153082 · 2016-02-04

Data da decisão2016-02-04

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Rampart A Lumbar Interbody Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K153082. 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 Rampart A Lumbar Interbody Fusion Device?

Rampart A Lumbar Interbody Fusion Device is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Spineology, Inc.. The 510(k) number is K153082.

When did Rampart A Lumbar Interbody Fusion Device receive FDA 510(k) clearance?

Rampart A Lumbar Interbody Fusion Device received FDA 510(k) clearance on 2016-02-04, under 510(k) number K153082.

Who is the listed applicant for Rampart A Lumbar Interbody Fusion Device?

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

What is the FDA product code for Rampart A Lumbar Interbody Fusion Device?

The FDA product code for Rampart A Lumbar Interbody Fusion Device is MAX.

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Fonte oficial

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