FDA 510(k)

C-VBR

N.º K: K152568 · 2016-02-11

Fecha de decisión2016-02-11

Código de productoPLR

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

C-VBR is the device name listed in this FDA 510(k) record. The listed applicant is Cardinal Spine, LLC. It received FDA 510(k) clearance on 2016-02-11 under 510(k) number K152568. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the C-VBR?

C-VBR is a medical device that received FDA 510(k) clearance on 2016-02-11. The listed applicant is Cardinal Spine, LLC. The 510(k) number is K152568.

When did C-VBR receive FDA 510(k) clearance?

C-VBR received FDA 510(k) clearance on 2016-02-11, under 510(k) number K152568.

Who is the listed applicant for C-VBR?

The FDA 510(k) record lists Cardinal Spine, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C-VBR?

The FDA product code for C-VBR is PLR.

Dispositivos relacionados (Código: PLR)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC K221542Galileo Vertebral Body Replacement DeviceBright Spine K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K211320CAPRI Corpectomy Cage SystemK2m, 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.