FDA 510(k)

Atlas™ Humeral Nail System

Número K: K241484 · 2024-11-05

RequerenteOrthopedic Designs North America, Inc. (Odi-Na)

Data da decisão2024-11-05

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Atlas™ Humeral Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Orthopedic Designs North America, Inc. (Odi-Na). It received FDA 510(k) clearance on 2024-11-05 under 510(k) number K241484. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Atlas™ Humeral Nail System?

Atlas™ Humeral Nail System is a medical device that received FDA 510(k) clearance on 2024-11-05. The listed applicant is Orthopedic Designs North America, Inc. (Odi-Na). The 510(k) number is K241484.

When did Atlas™ Humeral Nail System receive FDA 510(k) clearance?

Atlas™ Humeral Nail System received FDA 510(k) clearance on 2024-11-05, under 510(k) number K241484.

Who is the listed applicant for Atlas™ Humeral Nail System?

The FDA 510(k) record lists Orthopedic Designs North America, Inc. (Odi-Na) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Atlas™ Humeral Nail System?

The FDA product code for Atlas™ Humeral Nail System is HSB.

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