FDA 510(k)

NuVasive Lumbar Interbody Implants

N.º K: K161230 · 2016-08-25

Fecha de decisión2016-08-25

Código de productoMAX

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

NuVasive Lumbar Interbody Implants 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 2016-08-25 under 510(k) number K161230. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NuVasive Lumbar Interbody Implants?

NuVasive Lumbar Interbody Implants is a medical device that received FDA 510(k) clearance on 2016-08-25. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K161230.

When did NuVasive Lumbar Interbody Implants receive FDA 510(k) clearance?

NuVasive Lumbar Interbody Implants received FDA 510(k) clearance on 2016-08-25, under 510(k) number K161230.

Who is the listed applicant for NuVasive Lumbar Interbody Implants?

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 Lumbar Interbody Implants?

The FDA product code for NuVasive Lumbar Interbody Implants is MAX.

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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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Dispositivos relacionados (Código: MAX)

K261049SCALA® TLSpineart SA K261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics Corporation K253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

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