FDA 510(k)

Unison-C Anterior Cervical Fixation System

N.º K: K170830 · 2017-06-28

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

Fecha de decisión2017-06-28

Código de productoOVE

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Unison-C Anterior Cervical Fixation 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 2017-06-28 under 510(k) number K170830. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Unison-C Anterior Cervical Fixation System?

Unison-C Anterior Cervical Fixation System is a medical device that received FDA 510(k) clearance on 2017-06-28. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K170830.

When did Unison-C Anterior Cervical Fixation System receive FDA 510(k) clearance?

Unison-C Anterior Cervical Fixation System received FDA 510(k) clearance on 2017-06-28, under 510(k) number K170830.

Who is the listed applicant for Unison-C Anterior Cervical Fixation 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 Unison-C Anterior Cervical Fixation System?

The FDA product code for Unison-C Anterior Cervical Fixation System is OVE.

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Fuente oficial

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