FDA 510(k)

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System

N.º K: K231839 · 2023-07-19

Fecha de decisión2023-07-19

Código de productoKWQ

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System is the device name listed in this FDA 510(k) record. The listed applicant is L&K BIOMED Co., Ltd.. It received FDA 510(k) clearance on 2023-07-19 under 510(k) number K231839. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System?

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System is a medical device that received FDA 510(k) clearance on 2023-07-19. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K231839.

When did CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System receive FDA 510(k) clearance?

CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System received FDA 510(k) clearance on 2023-07-19, under 510(k) number K231839.

Who is the listed applicant for CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System?

The FDA 510(k) record lists L&K BIOMED Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System?

The FDA product code for CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System is KWQ.

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Otros registros que enlistan a L&K BIOMED Co., Ltd. como solicitante

K262489BluEX Cervical Expandable Cage System K260840BluEX Cervical Expandable Cage System K261112CastleLoc-P Anterior Cervical Plate System K261130Sistema de Fijación Espinal AccelFix K260448CastleLoc Pectus Bar System K251940PathLoc Lumbar Plate System

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Dispositivos relacionados (Código: KWQ)

K262149corra® cervical plating systemCarlsmed, Inc.K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLC K252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC

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.