FDA 510(k)

Parafusos Pediculares Porosos INTEGR8™ A8

Número K: K242827 · 2025-10-20

Data da decisão2025-10-20

Código do produtoNKB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

A8 INTEGR8™ Porous Pedicle Screws is the device name listed in this FDA 510(k) record. The listed applicant is Allumin8, Inc.. It received FDA 510(k) clearance on 2025-10-20 under 510(k) number K242827. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the A8 INTEGR8™ Porous Pedicle Screws?

A8 INTEGR8™ Porous Pedicle Screws is a medical device that received FDA 510(k) clearance on 2025-10-20. The listed applicant is Allumin8, Inc.. The 510(k) number is K242827.

When did A8 INTEGR8™ Porous Pedicle Screws receive FDA 510(k) clearance?

A8 INTEGR8™ Porous Pedicle Screws received FDA 510(k) clearance on 2025-10-20, under 510(k) number K242827.

Who is the listed applicant for A8 INTEGR8™ Porous Pedicle Screws?

The FDA 510(k) record lists Allumin8, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A8 INTEGR8™ Porous Pedicle Screws?

The FDA product code for A8 INTEGR8™ Porous Pedicle Screws is NKB.

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