FDA 510(k)

Arthrex Sterile VAL y VAL KreuLock® Sistema de Tornillo de Compresión Estéril

N.º K: K260809 · 2026-06-25

Fecha de decisión2026-06-25

Código de productoHWC

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2026-06-25 under 510(k) number K260809. 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 Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System?

Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System is a medical device that received FDA 510(k) clearance on 2026-06-25. The listed applicant is Arthrex, Inc.. The 510(k) number is K260809.

When did Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System receive FDA 510(k) clearance?

Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System received FDA 510(k) clearance on 2026-06-25, under 510(k) number K260809.

Who is the listed applicant for Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System?

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

What is the FDA product code for Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System?

The FDA product code for Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System is HWC. This falls under the Cardiovascular category.

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Otros registros que enlistan a Arthrex, Inc. como solicitante

K262975Sistema Arthrex Beaming K262618Tornillo de Compression FT de Espina Arthrex K262451Arthrex DynaNite Staples K262357Anclajes de Sutura Arthrex Bioabsorbibles PushLock K260624Arthrex Radial Head Replacement System K260018FiberButton Arthrex

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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.