FDA 510(k)

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional

N.º K: K221333 · 2022-12-29

Fecha de decisión2022-12-29

Código de productoHWC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Acumed, LLC. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K221333. 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 Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional?

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Acumed, LLC. The 510(k) number is K221333.

When did Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional receive FDA 510(k) clearance?

Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional received FDA 510(k) clearance on 2022-12-29, under 510(k) number K221333.

Who is the listed applicant for Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional?

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

What is the FDA product code for Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional?

The FDA product code for Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional is HWC. This falls under the Cardiovascular category.

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Otros registros que enlistan a Acumed, LLC como solicitante

K252356The Acumed Wrist Fixation System - 2.4mm Screws K251132The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - Screws K251296The Acumed Wrist Fixation System K243624Acu-Sinch Mini Sin Nudo K233311Acumed Wrist Plating System K230744Acumed Acutrak 3 Headless Compression Screw System

Ver todos los 9 dispositivos →

Dispositivos relacionados (Código: HWC)

K262975Sistema Arthrex BeamingArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps Ortho K261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower Orthoped K262344Large Compression ScrewsTriMed, Inc.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.