FDA 510(k)

HALF DOME Posterior Lumbar Interbody System

N.º K: K172947 · 2018-04-18

Fecha de decisión2018-04-18

Código de productoMAX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

HALF DOME Posterior Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Astura Medical. It received FDA 510(k) clearance on 2018-04-18 under 510(k) number K172947. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the HALF DOME Posterior Lumbar Interbody System?

HALF DOME Posterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2018-04-18. The listed applicant is Astura Medical. The 510(k) number is K172947.

When did HALF DOME Posterior Lumbar Interbody System receive FDA 510(k) clearance?

HALF DOME Posterior Lumbar Interbody System received FDA 510(k) clearance on 2018-04-18, under 510(k) number K172947.

Who is the listed applicant for HALF DOME Posterior Lumbar Interbody System?

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

What is the FDA product code for HALF DOME Posterior Lumbar Interbody System?

The FDA product code for HALF DOME Posterior Lumbar Interbody System is MAX.

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Otros registros que enlistan a Astura Medical como solicitante

K252885OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System K243259MASADA Modular Spinal Fixation System K240160EGPS Navigated Instruments K233359DOMINION Expandable Corpectomy System K231694MASADA Modular Spinal Fixation System

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Dispositivos relacionados (Código: MAX)

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.