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FDA 510(k)

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

Número K: K250472 · 2025-08-08

RequerenteAmdt Holdings, Inc.
Data da decisão2025-08-08
Código do produtoKTT
Comité consultivoOR
DecisãoSubstantially Equivalent

Resumo do dispositivo

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is the device name listed in this FDA 510(k) record. The listed applicant is Amdt Holdings, Inc.. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K250472. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Amdt Holdings, Inc.. The 510(k) number is K250472.

When did SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) receive FDA 510(k) clearance?

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) received FDA 510(k) clearance on 2025-08-08, under 510(k) number K250472.

Who is the listed applicant for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

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

What is the FDA product code for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?

The FDA product code for SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is KTT.

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Dispositivos Relacionados (Código: KTT)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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Fonte oficial

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