FDA 510(k)

FOCUS Pedicle Screw System

Número K: K180458 · 2018-04-17

RequerenteNvision Biomedical Technologies, LLC

Data da decisão2018-04-17

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FOCUS Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Nvision Biomedical Technologies, LLC. It received FDA 510(k) clearance on 2018-04-17 under 510(k) number K180458. 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 FOCUS Pedicle Screw System?

FOCUS Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2018-04-17. The listed applicant is Nvision Biomedical Technologies, LLC. The 510(k) number is K180458.

When did FOCUS Pedicle Screw System receive FDA 510(k) clearance?

FOCUS Pedicle Screw System received FDA 510(k) clearance on 2018-04-17, under 510(k) number K180458.

Who is the listed applicant for FOCUS Pedicle Screw System?

The FDA 510(k) record lists Nvision Biomedical Technologies, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOCUS Pedicle Screw System?

The FDA product code for FOCUS Pedicle Screw System is NKB.

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Fonte oficial

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