FDA 510(k)

Curiteva Porous PEEK Cervical Interbody Fusion System

N.º K: K213030 · 2023-02-13

Fecha de decisión2023-02-13

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Curiteva Porous PEEK Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Curiteva, Inc.. It received FDA 510(k) clearance on 2023-02-13 under 510(k) number K213030. 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 Curiteva Porous PEEK Cervical Interbody Fusion System?

Curiteva Porous PEEK Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-02-13. The listed applicant is Curiteva, Inc.. The 510(k) number is K213030.

When did Curiteva Porous PEEK Cervical Interbody Fusion System receive FDA 510(k) clearance?

Curiteva Porous PEEK Cervical Interbody Fusion System received FDA 510(k) clearance on 2023-02-13, under 510(k) number K213030.

Who is the listed applicant for Curiteva Porous PEEK Cervical Interbody Fusion System?

The FDA 510(k) record lists Curiteva, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Curiteva Porous PEEK Cervical Interbody Fusion System?

The FDA product code for Curiteva Porous PEEK Cervical Interbody Fusion System is ODP.

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Otros registros que enlistan a Curiteva, Inc. como solicitante

K252205Curiteva Porous PEEK Cervical Interbody System; Curiteva Porous PEEK Lumbar Interbody System; Curiteva Porous PEEK Laminoplasty System; Curiteva Porous PEEK Standalone ALIF System K254061Curiteva Porous PEEK Cervical Interbody Fusion System K250845Curiteva Porous PEEK Standalone ALIF System K243137Curiteva Porous PEEK Laminoplasty System K233360Curiteva Thoracolumbar Plate System K233744Curiteva Porous PEEK Lumbar Interbody Fusion System

Ver todos los 11 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

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