FDA 510(k)

NuVasive Reline System

Número K: K223181 · 2023-01-11

Data da decisão2023-01-11

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

NuVasive Reline 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 2023-01-11 under 510(k) number K223181. 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 NuVasive Reline System?

NuVasive Reline System is a medical device that received FDA 510(k) clearance on 2023-01-11. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K223181.

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

NuVasive Reline System received FDA 510(k) clearance on 2023-01-11, under 510(k) number K223181.

Who is the listed applicant for NuVasive Reline 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 Reline System?

The FDA product code for NuVasive Reline System is NKB.

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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 K221751NuVasive Cohere ALIF System Intervertebral Body Fusion Device K221388NuVasive Reline Cervical System K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System

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Fonte oficial

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