FDA 510(k)

OsteoCentric Technologies Cannulated Fasteners and Nuts

N.º K: K242691 · 2024-10-09

Fecha de decisión2024-10-09

Código de productoHWC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

OsteoCentric Technologies Cannulated Fasteners and Nuts is the device name listed in this FDA 510(k) record. The listed applicant is OsteoCentric Technologies. It received FDA 510(k) clearance on 2024-10-09 under 510(k) number K242691. 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 OsteoCentric Technologies Cannulated Fasteners and Nuts?

OsteoCentric Technologies Cannulated Fasteners and Nuts is a medical device that received FDA 510(k) clearance on 2024-10-09. The listed applicant is OsteoCentric Technologies. The 510(k) number is K242691.

When did OsteoCentric Technologies Cannulated Fasteners and Nuts receive FDA 510(k) clearance?

OsteoCentric Technologies Cannulated Fasteners and Nuts received FDA 510(k) clearance on 2024-10-09, under 510(k) number K242691.

Who is the listed applicant for OsteoCentric Technologies Cannulated Fasteners and Nuts?

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

What is the FDA product code for OsteoCentric Technologies Cannulated Fasteners and Nuts?

The FDA product code for OsteoCentric Technologies Cannulated Fasteners and Nuts is HWC. This falls under the Cardiovascular category.

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Otros registros que enlistan a OsteoCentric Technologies como solicitante

K251913OsteoCentric® UnifiMI® TCS Plating System K250494The OsteoCentric Bone Plate and Screw System K230242OsteoCentric Dental Implant System K230226Integrity-SI® Fusion System K230595OsteoCentric ACL Fixation System K230764OsteoCentric Integrated Hip Fastener System

Ver todos los 11 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 →

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