FDA 510(k)

CODA™ Anterior Cervical Plate System

Número K: K230993 · 2023-06-20

RequerentePioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech

Data da decisão2023-06-20

Código do produtoKWQ

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

CODA™ Anterior Cervical Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech. It received FDA 510(k) clearance on 2023-06-20 under 510(k) number K230993. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CODA™ Anterior Cervical Plate System?

CODA™ Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2023-06-20. The listed applicant is Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech. The 510(k) number is K230993.

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

CODA™ Anterior Cervical Plate System received FDA 510(k) clearance on 2023-06-20, under 510(k) number K230993.

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

The FDA 510(k) record lists Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech as the applicant. This does not by itself establish the device manufacturer.

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

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

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Fonte oficial

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