FDA 510(k)

Sistema de Fusion Interespinal Cervical Align

N.º K: K230639 · 2023-12-01

Fecha de decisión2023-12-01

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Align Cervical Interbody Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Surgical Devices, LLC. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K230639. 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 Align Cervical Interbody Fusion System?

Align Cervical Interbody Fusion System is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Acuity Surgical Devices, LLC. The 510(k) number is K230639.

When did Align Cervical Interbody Fusion System receive FDA 510(k) clearance?

Align Cervical Interbody Fusion System received FDA 510(k) clearance on 2023-12-01, under 510(k) number K230639.

Who is the listed applicant for Align Cervical Interbody Fusion System?

The FDA 510(k) record lists Acuity Surgical Devices, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Align Cervical Interbody Fusion System?

The FDA product code for Align Cervical Interbody Fusion System is ODP.

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Otros registros que enlistan a Acuity Surgical Devices, LLC como solicitante

K251735Stabilis SA Cervical Stand-Alone System (Various PNs)K251335Tera Lumbar Interbody Fusion System (Various PNs)K243386Ventris Intervertebral Body Fusion Device K241413sagAlign Lumbar Cage System (Various PNs)K222561Align K221535Sistema de Fusion Interespinal Lumbar Align

Ver todos los 8 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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