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FDA 510(k)

WishBone Medical Plate and Screw System

N.º K: K203467 · 2020-12-23

SolicitanteWishbone Medical, Inc.
Fecha de decisión2020-12-23
Código de productoHWC
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

WishBone Medical Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Wishbone Medical, Inc.. It received FDA 510(k) clearance on 2020-12-23 under 510(k) number K203467. 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 WishBone Medical Plate and Screw System?

WishBone Medical Plate and Screw System is a medical device that received FDA 510(k) clearance on 2020-12-23. The listed applicant is Wishbone Medical, Inc.. The 510(k) number is K203467.

When did WishBone Medical Plate and Screw System receive FDA 510(k) clearance?

WishBone Medical Plate and Screw System received FDA 510(k) clearance on 2020-12-23, under 510(k) number K203467.

Who is the listed applicant for WishBone Medical Plate and Screw System?

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

What is the FDA product code for WishBone Medical Plate and Screw System?

The FDA product code for WishBone Medical Plate and Screw System is HWC. This falls under the Cardiovascular category.

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Otros registros que enlistan a Wishbone Medical, Inc. 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.

K231461Smart Correction System (HA Half Pins)K230527WishBone Medical Plate and Screw SystemK221366Smart Correction System Rings and Compatible HA-Coated Half PinsK213489Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula PlateK193368Smart Correction SystemK180736WishBone Medical Plate and Screw System

Ver todos los 8 dispositivos →

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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