FDA 510(k)

Femoral Trochanteric Nail System – Neonail

N.º K: K221021 · 2022-12-06

SolicitanteNeoortho Produtos Ortopédicos S/A

Fecha de decisión2022-12-06

Código de productoHSB

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Femoral Trochanteric Nail System – Neonail is the device name listed in this FDA 510(k) record. The listed applicant is Neoortho Produtos Ortopédicos S/A. It received FDA 510(k) clearance on 2022-12-06 under 510(k) number K221021. 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 Femoral Trochanteric Nail System – Neonail?

Femoral Trochanteric Nail System – Neonail is a medical device that received FDA 510(k) clearance on 2022-12-06. The listed applicant is Neoortho Produtos Ortopédicos S/A. The 510(k) number is K221021.

When did Femoral Trochanteric Nail System – Neonail receive FDA 510(k) clearance?

Femoral Trochanteric Nail System – Neonail received FDA 510(k) clearance on 2022-12-06, under 510(k) number K221021.

Who is the listed applicant for Femoral Trochanteric Nail System – Neonail?

The FDA 510(k) record lists Neoortho Produtos Ortopédicos S/A as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Femoral Trochanteric Nail System – Neonail?

The FDA product code for Femoral Trochanteric Nail System – Neonail is HSB.

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Fuente oficial

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