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FDA 510(k)

DAC Dynamic Active Compression Plate

N.º K: K200513 · 2020-07-22

SolicitantePioneer Surgical Technology, Inc., Dba Rti Surgical
Fecha de decisión2020-07-22
Código de productoHRS
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

DAC Dynamic Active Compression Plate is the device name listed in this FDA 510(k) record. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical. It received FDA 510(k) clearance on 2020-07-22 under 510(k) number K200513. 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 DAC Dynamic Active Compression Plate?

DAC Dynamic Active Compression Plate is a medical device that received FDA 510(k) clearance on 2020-07-22. The listed applicant is Pioneer Surgical Technology, Inc., Dba Rti Surgical. The 510(k) number is K200513.

When did DAC Dynamic Active Compression Plate receive FDA 510(k) clearance?

DAC Dynamic Active Compression Plate received FDA 510(k) clearance on 2020-07-22, under 510(k) number K200513.

Who is the listed applicant for DAC Dynamic Active Compression Plate?

The FDA 510(k) record lists Pioneer Surgical Technology, Inc., Dba Rti Surgical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DAC Dynamic Active Compression Plate?

The FDA product code for DAC Dynamic Active Compression Plate 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

Ver en la base de datos de la FDA →

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