FDA 510(k)

Spinal Elements' Spinous Process Plate System

Número K: K160465 · 2016-07-28

Data da decisão2016-07-28

Código do produtoPEK

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Spinal Elements' Spinous Process Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Elements, Inc.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K160465. The device is classified under product code PEK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Spinal Elements' Spinous Process Plate System?

Spinal Elements' Spinous Process Plate System is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Spinal Elements, Inc.. The 510(k) number is K160465.

When did Spinal Elements' Spinous Process Plate System receive FDA 510(k) clearance?

Spinal Elements' Spinous Process Plate System received FDA 510(k) clearance on 2016-07-28, under 510(k) number K160465.

Who is the listed applicant for Spinal Elements' Spinous Process Plate System?

The FDA 510(k) record lists Spinal Elements, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spinal Elements' Spinous Process Plate System?

The FDA product code for Spinal Elements' Spinous Process Plate System is PEK.

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Fonte oficial

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