FDA 510(k)

Fule Interbody Fusion Cage System

Número K: K253151 · 2026-06-15

RequerenteBeijing Fule Science & Technology Development Co., Ltd.

Data da decisão2026-06-15

Código do produtoMAX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Fule Interbody Fusion Cage System is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K253151. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Fule Interbody Fusion Cage System?

Fule Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Beijing Fule Science & Technology Development Co., Ltd.. The 510(k) number is K253151.

When did Fule Interbody Fusion Cage System receive FDA 510(k) clearance?

Fule Interbody Fusion Cage System received FDA 510(k) clearance on 2026-06-15, under 510(k) number K253151.

Who is the listed applicant for Fule Interbody Fusion Cage System?

The FDA 510(k) record lists Beijing Fule Science & Technology Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fule Interbody Fusion Cage System?

The FDA product code for Fule Interbody Fusion Cage System is MAX.

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Fonte oficial

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