FDA 510(k)

CervAlign™ Anterior Cervical Plate System

N.º K: K183060 · 2019-01-17

SolicitantePioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)

Fecha de decisión2019-01-17

Código de productoKWQ

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

CervAlign™ Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). It received FDA 510(k) clearance on 2019-01-17 under 510(k) number K183060. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CervAlign™ Anterior Cervical Plate System?

CervAlign™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2019-01-17. The listed applicant is Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). The 510(k) number is K183060.

When did CervAlign™ Anterior Cervical Plate System receive FDA 510(k) clearance?

CervAlign™ Anterior Cervical Plate System received FDA 510(k) clearance on 2019-01-17, under 510(k) number K183060.

Who is the listed applicant for CervAlign™ Anterior Cervical Plate System?

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

What is the FDA product code for CervAlign™ Anterior Cervical Plate System?

The FDA product code for CervAlign™ Anterior Cervical Plate System is KWQ.

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Otros registros que enlistan a Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) como solicitante

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Fuente oficial

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