FDA 510(k)

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants

N.º K: K250713 · 2025-12-01

Fecha de decisión2025-12-01

Código de productoKWT

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2025-12-01 under 510(k) number K250713. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants?

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants is a medical device that received FDA 510(k) clearance on 2025-12-01. The listed applicant is Exactech, Inc.. The 510(k) number is K250713.

When did Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants receive FDA 510(k) clearance?

Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants received FDA 510(k) clearance on 2025-12-01, under 510(k) number K250713.

Who is the listed applicant for Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants?

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

What is the FDA product code for Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants?

The FDA product code for Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants is KWT.

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Otros registros que enlistan a Exactech, Inc. como solicitante

K260583Equinoxe® Shoulder System K243448Equinoxe® Shoulder System K243275Equinoxe® Scapula Fracture System K243839Vástago Femoral Alteon® HA K240393Exactech® TRULIANT® Knee System K233482Equinoxe® Central Screw Baseplate System

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Dispositivos relacionados (Código: KWT)

K262173N22 Offset Humeral HeadShoulder Innovations, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944Sistema de Reemplazo de Hombro AGILON® XOImplantcast GmbH K241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657Sistema de Reemplazo de Hombro AGILON® XOImplantcast GmbH K223631Comprehensive Segmental Revision System(SRS)Biomet Orthopedics

Fuente oficial

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