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FDA 510(k)

SkyOPS™ Orthopedic Plate System

N.º K: K233154 · 2023-12-21

SolicitanteSky Surgical, LLC
Fecha de decisión2023-12-21
Código de productoHRS
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

SkyOPS™ Orthopedic Plate System is the device name listed in this FDA 510(k) record. The listed applicant is Sky Surgical, LLC. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K233154. 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 SkyOPS™ Orthopedic Plate System?

SkyOPS™ Orthopedic Plate System is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Sky Surgical, LLC. The 510(k) number is K233154.

When did SkyOPS™ Orthopedic Plate System receive FDA 510(k) clearance?

SkyOPS™ Orthopedic Plate System received FDA 510(k) clearance on 2023-12-21, under 510(k) number K233154.

Who is the listed applicant for SkyOPS™ Orthopedic Plate System?

The FDA 510(k) record lists Sky Surgical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SkyOPS™ Orthopedic Plate System?

The FDA product code for SkyOPS™ Orthopedic Plate System 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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