FDA 510(k)

Gemini Cervical Fusion Cage System

N.º K: K242195 · 2024-11-04

SolicitanteZheJiang Decans Medical Devices Co., Ltd.

Fecha de decisión2024-11-04

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Gemini Cervical Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-11-04 under 510(k) number K242195. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Gemini Cervical Fusion Cage System?

Gemini Cervical Fusion Cage System is a medical device that received FDA 510(k) clearance on 2024-11-04. The listed applicant is ZheJiang Decans Medical Devices Co., Ltd.. The 510(k) number is K242195.

When did Gemini Cervical Fusion Cage System receive FDA 510(k) clearance?

Gemini Cervical Fusion Cage System received FDA 510(k) clearance on 2024-11-04, under 510(k) number K242195.

Who is the listed applicant for Gemini Cervical Fusion Cage System?

The FDA 510(k) record lists ZheJiang Decans Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gemini Cervical Fusion Cage System?

The FDA product code for Gemini Cervical Fusion Cage System is ODP.

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Dispositivos relacionados (Código: ODP)

K262595VariLift-C Cervical Interbody Fusion SystemWenzel Spine, Inc.K262489BluEX Cervical Expandable Cage SystemL&K BIOMED Co., Ltd.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.

Fuente oficial

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