FDA 510(k)

Unison-C Anterior Cervical Fixation System

Número K: K152793 · 2016-01-19

RequerentePioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.

Data da decisão2016-01-19

Código do produtoOVE

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do 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 2016-01-19 under 510(k) number K152793. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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 2016-01-19. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.. The 510(k) number is K152793.

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 2016-01-19, under 510(k) number K152793.

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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Fonte oficial

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