FDA 510(k)

Kentrospine PSS Pedicle Screw System

Número K: K220486 · 2022-07-22

RequerenteRivarp Medical Private Limited

Data da decisão2022-07-22

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kentrospine PSS Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Rivarp Medical Private Limited. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K220486. 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 Kentrospine PSS Pedicle Screw System?

Kentrospine PSS Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Rivarp Medical Private Limited. The 510(k) number is K220486.

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

Kentrospine PSS Pedicle Screw System received FDA 510(k) clearance on 2022-07-22, under 510(k) number K220486.

Who is the listed applicant for Kentrospine PSS Pedicle Screw System?

The FDA 510(k) record lists Rivarp Medical Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kentrospine PSS Pedicle Screw System?

The FDA product code for Kentrospine PSS Pedicle Screw System is NKB.

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Dispositivos Relacionados (Código: NKB)

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Fonte oficial

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