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FDA 510(k)

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System

N.º K: K220413 · 2022-06-22

SolicitanteCanary Medical USA, LLC
Fecha de decisión2022-06-22
Código de productoQPP
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is the device name listed in this FDA 510(k) record. The listed applicant is Canary Medical USA, LLC. It received FDA 510(k) clearance on 2022-06-22 under 510(k) number K220413. The device is classified under product code QPP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System?

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Canary Medical USA, LLC. The 510(k) number is K220413.

When did Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System receive FDA 510(k) clearance?

Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System received FDA 510(k) clearance on 2022-06-22, under 510(k) number K220413.

Who is the listed applicant for Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System?

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

What is the FDA product code for Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System?

The FDA product code for Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System is QPP.

Ensayos clínicos relacionados

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Otros registros que enlistan a Canary Medical USA, LLC como solicitante

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.

K234056canturio® se (Canturio Smart Extension)K223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System

Dispositivos relacionados (Código: QPP)

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.

K234056canturio® se (Canturio Smart Extension)Canary Medical USA, LLCK223803Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) SystemCanary Medical USA, LLC

Fuente oficial

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