FDA 510(k)

4CIS® Chiron Spinal Fixation System

N.º K: K231655 · 2024-11-26

Fecha de decisión2024-11-26

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 2024-11-26 under 510(k) number K231655. 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 2024-11-26. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K231655.

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

4CIS® Chiron Spinal Fixation System received FDA 510(k) clearance on 2024-11-26, under 510(k) number K231655.

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

K203233SISTEMA DE FIJACIÓN ESPINAL CHIRON 4CIS 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)

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim Sirketi K262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix Medical K262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.O K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Fuente oficial

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