FDA 510(k)

Threshold™ Pedicular Fixation System

Número K: K161694 · 2016-07-15

Data da decisão2016-07-15

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Threshold™ Pedicular Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161694. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Threshold™ Pedicular Fixation System?

Threshold™ Pedicular Fixation System is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Spineology, Inc.. The 510(k) number is K161694.

When did Threshold™ Pedicular Fixation System receive FDA 510(k) clearance?

Threshold™ Pedicular Fixation System received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161694.

Who is the listed applicant for Threshold™ Pedicular Fixation System?

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

What is the FDA product code for Threshold™ Pedicular Fixation System?

The FDA product code for Threshold™ Pedicular Fixation System is NKB.

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Fonte oficial

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