FDA 510(k)

SISTEMA DE FIJACIÓN ESPINAL CHIRON 4CIS

N.º K: K203233 · 2022-06-01

Fecha de decisión2022-06-01

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

4CIS Chiron Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2022-06-01 under 510(k) number K203233. 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 Chiron Spinal Fixation System?

4CIS Chiron Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-06-01. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K203233.

When did 4CIS Chiron Spinal Fixation System receive FDA 510(k) clearance?

4CIS Chiron Spinal Fixation System received FDA 510(k) clearance on 2022-06-01, under 510(k) number K203233.

Who is the listed applicant for 4CIS Chiron Spinal Fixation System?

The FDA 510(k) record lists Solco Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS Chiron Spinal Fixation System?

The FDA product code for 4CIS Chiron Spinal Fixation System is NKB.

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Otros registros que enlistan a Solco Biomedical Co., Ltd. como solicitante

K2316554CIS® Chiron Spinal Fixation System K192044CAGE DE ACIF DE PEEK MARLIN 4CIS K190563CAGE DE PLIF DE PEEK 4CIS, CAGE DE PLIF DE PEEK PEBBLE BEACH 4CIS, CAGE DE TLIF DE PEEK TORREY PINES 4CIS, CAGE DE DLIF DE PEEK DUNES 4CIS, CAGE DE ALIF DE PEEK AUGUSTA 4CIS K1904714CIS® Chiron Spinal Fixation System K1824894CIS® Pinehurst Anterior Cervical Plate system K1624024CIS® Marlin ACIF Cage System

Ver todos los 7 dispositivos →

Dispositivos relacionados (Código: NKB)

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Fuente oficial

Ver en la base de datos de la FDA →

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