FDA 510(k)

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.

N.º K: K223565 · 2022-12-23

Fecha de decisión2022-12-23

Código de productoNKB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation 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 2022-12-23 under 510(k) number K223565. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.?

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. is a medical device that received FDA 510(k) clearance on 2022-12-23. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K223565.

When did LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. receive FDA 510(k) clearance?

LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. received FDA 510(k) clearance on 2022-12-23, under 510(k) number K223565.

Who is the listed applicant for LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation 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 LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.?

The FDA product code for LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. is NKB.

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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: NKB)

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Fuente oficial

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