FDA 510(k)

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw

N.º K: K231819 · 2023-09-05

SolicitanteInnovate Orthopaedics Limited

Fecha de decisión2023-09-05

Código de productoHWC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is the device name listed in this FDA 510(k) record. The listed applicant is Innovate Orthopaedics Limited. It received FDA 510(k) clearance on 2023-09-05 under 510(k) number K231819. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is a medical device that received FDA 510(k) clearance on 2023-09-05. The listed applicant is Innovate Orthopaedics Limited. The 510(k) number is K231819.

When did Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw receive FDA 510(k) clearance?

Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw received FDA 510(k) clearance on 2023-09-05, under 510(k) number K231819.

Who is the listed applicant for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

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

What is the FDA product code for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw?

The FDA product code for Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw is HWC. This falls under the Cardiovascular category.

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Otros registros que enlistan a Innovate Orthopaedics Limited como solicitante

K212547Quick-Start Screws

Dispositivos relacionados (Código: HWC)

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Fuente oficial

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