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FDA 510(k)

OsteoCoil™ Nitinol Compression System (Multiple Component PNs)

N.º K: K233567 · 2024-11-22

SolicitanteFlower Orthopedics Corporation Dba Conventus Flower Ortho
Fecha de decisión2024-11-22
Código de productoHWC
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

OsteoCoil™ Nitinol Compression System (Multiple Component PNs) is the device name listed in this FDA 510(k) record. The listed applicant is Flower Orthopedics Corporation Dba Conventus Flower Ortho. It received FDA 510(k) clearance on 2024-11-22 under 510(k) number K233567. 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 OsteoCoil™ Nitinol Compression System (Multiple Component PNs)?

OsteoCoil™ Nitinol Compression System (Multiple Component PNs) is a medical device that received FDA 510(k) clearance on 2024-11-22. The listed applicant is Flower Orthopedics Corporation Dba Conventus Flower Ortho. The 510(k) number is K233567.

When did OsteoCoil™ Nitinol Compression System (Multiple Component PNs) receive FDA 510(k) clearance?

OsteoCoil™ Nitinol Compression System (Multiple Component PNs) received FDA 510(k) clearance on 2024-11-22, under 510(k) number K233567.

Who is the listed applicant for OsteoCoil™ Nitinol Compression System (Multiple Component PNs)?

The FDA 510(k) record lists Flower Orthopedics Corporation Dba Conventus Flower Ortho as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OsteoCoil™ Nitinol Compression System (Multiple Component PNs)?

The FDA product code for OsteoCoil™ Nitinol Compression System (Multiple Component PNs) is HWC. This falls under the Cardiovascular category.

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Dispositivos relacionados (Código: HWC)

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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