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FDA 510(k)

Sistema de Tornillo de Compresión Accelerate - Código de Producto Pequeño ACC-S; Sistema de Tornillo de Compresión Accelerate - Código de Producto Mediano ACC-M; Sistema de Tornillo de Compresión Accelerate - Código de Producto Grande ACC-L

N.º K: K230946 · 2023-09-15

SolicitanteTrax Surgical
Fecha de decisión2023-09-15
Código de productoHWC
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L is the device name listed in this FDA 510(k) record. The listed applicant is Trax Surgical. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K230946. 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 Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L?

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Trax Surgical. The 510(k) number is K230946.

When did Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L receive FDA 510(k) clearance?

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L received FDA 510(k) clearance on 2023-09-15, under 510(k) number K230946.

Who is the listed applicant for Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L?

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

What is the FDA product code for Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L?

The FDA product code for Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L is HWC. This falls under the Cardiovascular category.

Ensayos clínicos relacionados

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Otros registros que enlistan a Trax Surgical 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.

K250712Linkt Compression Staple System

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.

K262975Sistema Arthrex BeamingArthrex, Inc.K260995DynaNail Helix® Fixation SystemMedShape, Inc.K254280F.A.S.T ScrewSteps OrthoK261057ActivaScrew™ Cannulated COMBioretec, Ltd.K260106OsteoCoil™ GT Active Compression SystemFlower Orthopedics Corporation DBA Conventus Flower OrthopedK262344Large 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.

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