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FDA 510(k)

SISTEMA DE ESPINA SARA 4CIS, SISTEMA DE ESPINA VERTU 4CIS, SISTEMA DE ESCURO PEDICLE 4CIS, SISTEMA DE FIJACIÓN ESPINAL aBle, SISTEMA DE FIJACIÓN ESPINAL aBle Xt

N.º K: K232607 · 2024-02-27

SolicitanteSolco Biomedical Copany India Private Limited
Fecha de decisión2024-02-27
Código de productoNKB
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Copany India Private Limited. It received FDA 510(k) clearance on 2024-02-27 under 510(k) number K232607. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM?

4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2024-02-27. The listed applicant is Solco Biomedical Copany India Private Limited. The 510(k) number is K232607.

When did 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM receive FDA 510(k) clearance?

4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM received FDA 510(k) clearance on 2024-02-27, under 510(k) number K232607.

Who is the listed applicant for 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM?

The FDA 510(k) record lists Solco Biomedical Copany India Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM?

The FDA product code for 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM is NKB.

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Dispositivos relacionados (Código: NKB)

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.

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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.

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