FDA 510(k)

Rod Registration Frame

N.º K: K230989 · 2023-05-05

Fecha de decisión2023-05-05

Código de productoOLO

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Rod Registration Frame 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 2023-05-05 under 510(k) number K230989. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Rod Registration Frame?

Rod Registration Frame is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K230989.

When did Rod Registration Frame receive FDA 510(k) clearance?

Rod Registration Frame received FDA 510(k) clearance on 2023-05-05, under 510(k) number K230989.

Who is the listed applicant for Rod Registration Frame?

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 Rod Registration Frame?

The FDA product code for Rod Registration Frame is OLO.

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Otros registros que enlistan a Nu Vasive, Incorporated como solicitante

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 K223181NuVasive Reline System 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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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.