FDA 510(k)

A’TOMIC™ Nitinol Fixation System

Número K: K232990 · 2024-01-12

Data da decisão2024-01-12

Código do produtoJDR

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

A’TOMIC™ Nitinol Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Rmr Ortho, LLC. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K232990. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the A’TOMIC™ Nitinol Fixation System?

A’TOMIC™ Nitinol Fixation System is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Rmr Ortho, LLC. The 510(k) number is K232990.

When did A’TOMIC™ Nitinol Fixation System receive FDA 510(k) clearance?

A’TOMIC™ Nitinol Fixation System received FDA 510(k) clearance on 2024-01-12, under 510(k) number K232990.

Who is the listed applicant for A’TOMIC™ Nitinol Fixation System?

The FDA 510(k) record lists Rmr Ortho, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for A’TOMIC™ Nitinol Fixation System?

The FDA product code for A’TOMIC™ Nitinol Fixation System is JDR.

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Fonte oficial

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