FDA 510(k)

NuVasive Reline Cervical System

N.º K: K221388 · 2022-09-09

Fecha de decisión2022-09-09

Código de productoNKG

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

NuVasive Reline Cervical 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 2022-09-09 under 510(k) number K221388. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NuVasive Reline Cervical System?

NuVasive Reline Cervical System is a medical device that received FDA 510(k) clearance on 2022-09-09. The listed applicant is Nu Vasive, Incorporated. The 510(k) number is K221388.

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

NuVasive Reline Cervical System received FDA 510(k) clearance on 2022-09-09, under 510(k) number K221388.

Who is the listed applicant for NuVasive Reline Cervical 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 Cervical System?

The FDA product code for NuVasive Reline Cervical System is NKG.

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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 K220478NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System

Ver todos los 79 dispositivos →

Dispositivos relacionados (Código: NKG)

K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd.K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics , Ltd.K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG K253129Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

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