FDA 510(k)

NuVasive® VersaTie System

Número K: K161265 · 2016-07-15

Data da decisão2016-07-15

Código do produtoOWI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

NuVasive® VersaTie System is the device name listed in this FDA 510(k) record. The listed applicant is Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161265. The device is classified under product code OWI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NuVasive® VersaTie System?

NuVasive® VersaTie System is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K161265.

When did NuVasive® VersaTie System receive FDA 510(k) clearance?

NuVasive® VersaTie System received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161265.

Who is the listed applicant for NuVasive® VersaTie System?

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

What is the FDA product code for NuVasive® VersaTie System?

The FDA product code for NuVasive® VersaTie System is OWI.

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Outros registros que listam Nu Vasive, Incorporated como candidato(a)

K231735NuVasive CoRoent Small Interbody System; NuVasive CoRoent Small Contoured Interbody System; NuVasive CoRoent Small Interlock System; NuVasive CoRoent Small Interlock II System; NuVasive CoRoent Small Ti-C System; NuVasive Cohere Cervical Interbody System K230894NuVasive Modulus ALIF System K230989Rod Registration Frame K223181NuVasive Reline System K221751NuVasive Cohere ALIF System Intervertebral Body Fusion Device K221388NuVasive Reline Cervical System

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Fonte oficial

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