FDA 510(k)

BluEX Cervical Expandable Cage System

Número K: K262489 · 2026-08-18

Data da decisão2026-08-18

Código do produtoODP

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

BluEX Cervical Expandable Cage 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 2026-08-18 under 510(k) number K262489. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BluEX Cervical Expandable Cage System?

BluEX Cervical Expandable Cage System is a medical device that received FDA 510(k) clearance on 2026-08-18. The listed applicant is L&K BIOMED Co., Ltd.. The 510(k) number is K262489.

When did BluEX Cervical Expandable Cage System receive FDA 510(k) clearance?

BluEX Cervical Expandable Cage System received FDA 510(k) clearance on 2026-08-18, under 510(k) number K262489.

Who is the listed applicant for BluEX Cervical Expandable Cage 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 BluEX Cervical Expandable Cage System?

The FDA product code for BluEX Cervical Expandable Cage System is ODP.

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Outros registros que listam L&K BIOMED Co., Ltd. como candidato(a)

K260840BluEX Cervical Expandable Cage System K261112CastleLoc-P Anterior Cervical Plate System K261130AccelFix Spinal Fixation System K260448CastleLoc Pectus Bar System K251940PathLoc Lumbar Plate System K251741PathLoc Lumbar Interbody Fusion Cage System

Ver todos os 39 dispositivos →

Dispositivos Relacionados (Código: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K2530413d Cage CervicalFims Co., Ltd.K262061Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior Lumbar Cage; Aero® -C Cervical Cage System; AVS® Anchor-C Cervical Cage System; AVS® TL PEEK Spacer; AVS® PL PEEK Spacers; AVS® Navigator PEEK Spacer; AVS® AS PEEK Spacer; Monterey™ AL Interbody System; Aleutian IBF System; Cascadia Interbody System; Chesapeake Stabilization System; Sahara Stabilization System; SANTORINI™ Corpectomy Cage System; MOJAVE Interbody System; VLIFT VERTEBRAL BODY REPLACEMStryker Spine K254130C.A. Medical Interbody Fusion SystemC.A. Medical, LLC K260840BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.K260850OSTEOMNI SPINAL CAGES SYSTEMOsteomni, Inc.

Fonte oficial

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