FDA 510(k)

NuVasive CoRoent Small Ti-C System

N.º K: K162138 · 2016-10-26

Fecha de decisión2016-10-26

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

NuVasive CoRoent Small Ti-C 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 2016-10-26 under 510(k) number K162138. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NuVasive CoRoent Small Ti-C System?

NuVasive CoRoent Small Ti-C System is a medical device that received FDA 510(k) clearance on 2016-10-26. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K162138.

When did NuVasive CoRoent Small Ti-C System receive FDA 510(k) clearance?

NuVasive CoRoent Small Ti-C System received FDA 510(k) clearance on 2016-10-26, under 510(k) number K162138.

Who is the listed applicant for NuVasive CoRoent Small Ti-C 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 CoRoent Small Ti-C System?

The FDA product code for NuVasive CoRoent Small Ti-C System is ODP.

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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 K230989Rod Registration Frame K223181NuVasive Reline System K221751NuVasive Cohere ALIF System Intervertebral Body Fusion Device K221388NuVasive Reline Cervical System

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Fuente oficial

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