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FDA 510(k)

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

N.º K: K250472 · 2025-08-08

SolicitanteAmdt Holdings, Inc.
Fecha de decisión2025-08-08
Código de productoKTT
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLCK260900DYNEX® External Fixation SystemsVilex, LLCK260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc.K253291Excelsior SystemBlue Ocean GlobalK253613Monkey Rings External Ring Fixation SystemParagon 28, Inc.K253202Hoffmann LRF SystemStryker GmbH

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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