FDA 510(k)

Sistema de Parafuso TRIGEN INTERTAN 10S

Número K: K241804 · 2024-08-22

Data da decisão2024-08-22

Código do produtoJDS

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

TRIGEN INTERTAN 10S Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2024-08-22 under 510(k) number K241804. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the TRIGEN INTERTAN 10S Nail System?

TRIGEN INTERTAN 10S Nail System is a medical device that received FDA 510(k) clearance on 2024-08-22. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K241804.

When did TRIGEN INTERTAN 10S Nail System receive FDA 510(k) clearance?

TRIGEN INTERTAN 10S Nail System received FDA 510(k) clearance on 2024-08-22, under 510(k) number K241804.

Who is the listed applicant for TRIGEN INTERTAN 10S Nail System?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRIGEN INTERTAN 10S Nail System?

The FDA product code for TRIGEN INTERTAN 10S Nail System is JDS.

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Fonte oficial

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