FDA 510(k)

DualX Lumbar Intervertebral Body Fusion Device

Número K: K192434 · 2019-10-15

Data da decisão2019-10-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

DualX Lumbar Intervertebral Body Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Amplify Surgical, Inc.. It received FDA 510(k) clearance on 2019-10-15 under 510(k) number K192434. 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 DualX Lumbar Intervertebral Body Fusion Device?

DualX Lumbar Intervertebral Body Fusion Device is a medical device that received FDA 510(k) clearance on 2019-10-15. The listed applicant is Amplify Surgical, Inc.. The 510(k) number is K192434.

When did DualX Lumbar Intervertebral Body Fusion Device receive FDA 510(k) clearance?

DualX Lumbar Intervertebral Body Fusion Device received FDA 510(k) clearance on 2019-10-15, under 510(k) number K192434.

Who is the listed applicant for DualX Lumbar Intervertebral Body Fusion Device?

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

What is the FDA product code for DualX Lumbar Intervertebral Body Fusion Device?

The FDA product code for DualX Lumbar Intervertebral Body Fusion Device is MAX.

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Outros registros que listam Amplify Surgical, Inc. como candidato(a)

K222203DualXSLIM(R) T/PLIF K211740DualX

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Fonte oficial

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