FDA 510(k)

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA

N.º K: K253991 · 2026-05-08

Fecha de decisión2026-05-08

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K253991. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA?

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Orthofix Srl. The 510(k) number is K253991.

When did Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA receive FDA 510(k) clearance?

Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA received FDA 510(k) clearance on 2026-05-08, under 510(k) number K253991.

Who is the listed applicant for Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA?

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

What is the FDA product code for Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA?

The FDA product code for Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA is HSB.

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Otros registros que enlistan a Orthofix Srl como solicitante

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Dispositivos relacionados (Código: HSB)

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Fuente oficial

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