FDA 510(k)

Flex-Z™ Cervical Cage

N.º K: K252432 · 2026-03-25

Fecha de decisión2026-03-25

Código de productoODP

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Flex-Z™ Cervical Cage is the device name listed in this FDA 510(k) record. The listed applicant is Spinepoint, LLC. It received FDA 510(k) clearance on 2026-03-25 under 510(k) number K252432. 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 Flex-Z™ Cervical Cage?

Flex-Z™ Cervical Cage is a medical device that received FDA 510(k) clearance on 2026-03-25. The listed applicant is Spinepoint, LLC. The 510(k) number is K252432.

When did Flex-Z™ Cervical Cage receive FDA 510(k) clearance?

Flex-Z™ Cervical Cage received FDA 510(k) clearance on 2026-03-25, under 510(k) number K252432.

Who is the listed applicant for Flex-Z™ Cervical Cage?

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

What is the FDA product code for Flex-Z™ Cervical Cage?

The FDA product code for Flex-Z™ Cervical Cage 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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