FDA 510(k)

Viking Lumbar Polyaxial Screw System

Número K: K180655 · 2018-07-13

Data da decisão2018-07-13

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Viking Lumbar Polyaxial Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Presidio Surgical. It received FDA 510(k) clearance on 2018-07-13 under 510(k) number K180655. 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 Viking Lumbar Polyaxial Screw System?

Viking Lumbar Polyaxial Screw System is a medical device that received FDA 510(k) clearance on 2018-07-13. The listed applicant is Presidio Surgical. The 510(k) number is K180655.

When did Viking Lumbar Polyaxial Screw System receive FDA 510(k) clearance?

Viking Lumbar Polyaxial Screw System received FDA 510(k) clearance on 2018-07-13, under 510(k) number K180655.

Who is the listed applicant for Viking Lumbar Polyaxial Screw System?

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

What is the FDA product code for Viking Lumbar Polyaxial Screw System?

The FDA product code for Viking Lumbar Polyaxial Screw System is NKB.

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