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FDA 510(k)

CoLink NeoFuse MIS Plating System (see attached parts list)

N.º K: K241387 · 2024-08-13

SolicitanteIn2bones USA
Fecha de decisión2024-08-13
Código de productoHRS
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

CoLink NeoFuse MIS Plating System (see attached parts list) is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241387. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CoLink NeoFuse MIS Plating System (see attached parts list)?

CoLink NeoFuse MIS Plating System (see attached parts list) is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is In2bones USA. The 510(k) number is K241387.

When did CoLink NeoFuse MIS Plating System (see attached parts list) receive FDA 510(k) clearance?

CoLink NeoFuse MIS Plating System (see attached parts list) received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241387.

Who is the listed applicant for CoLink NeoFuse MIS Plating System (see attached parts list)?

The FDA 510(k) record lists In2bones USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLink NeoFuse MIS Plating System (see attached parts list)?

The FDA product code for CoLink NeoFuse MIS Plating System (see attached parts list) is HRS.

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Dispositivos relacionados (Código: HRS)

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

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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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