FDA 510(k)

PYXIS 3D Titanium Cervical Cage system

N.º K: K241738 · 2024-08-20

Fecha de decisión2024-08-20

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

PYXIS 3D Titanium Cervical Cage system is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-08-20 under 510(k) number K241738. 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 PYXIS 3D Titanium Cervical Cage system?

PYXIS 3D Titanium Cervical Cage system is a medical device that received FDA 510(k) clearance on 2024-08-20. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K241738.

When did PYXIS 3D Titanium Cervical Cage system receive FDA 510(k) clearance?

PYXIS 3D Titanium Cervical Cage system received FDA 510(k) clearance on 2024-08-20, under 510(k) number K241738.

Who is the listed applicant for PYXIS 3D Titanium Cervical Cage system?

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

What is the FDA product code for PYXIS 3D Titanium Cervical Cage system?

The FDA product code for PYXIS 3D Titanium Cervical Cage system is ODP.

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Otros registros que enlistan a GS Medical Co., Ltd. como solicitante

K254260The VEGA Cervical Screw System K243073AnyPlus Sistema de Instrumentos Navegados K240350AnyPlus II Sistema de Fijación Espinal K231808QUASAR Standalone ACIF System K223868PYXIS 3D Titanium Cage System K222041CYGNUS-C Standalone ACIF System

Ver todos los 14 dispositivos →

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

Ver en la base de datos de la FDA →

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