FDA 510(k)

TRIGEN META-TAN Trochanteric Antegrade Nail

Número K: K243364 · 2024-12-09

Data da decisão2024-12-09

Código do produtoHSB

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

TRIGEN META-TAN Trochanteric Antegrade Nail 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 2024-12-09 under 510(k) number K243364. 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 TRIGEN META-TAN Trochanteric Antegrade Nail?

TRIGEN META-TAN Trochanteric Antegrade Nail is a medical device that received FDA 510(k) clearance on 2024-12-09. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K243364.

When did TRIGEN META-TAN Trochanteric Antegrade Nail receive FDA 510(k) clearance?

TRIGEN META-TAN Trochanteric Antegrade Nail received FDA 510(k) clearance on 2024-12-09, under 510(k) number K243364.

Who is the listed applicant for TRIGEN META-TAN Trochanteric Antegrade Nail?

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 META-TAN Trochanteric Antegrade Nail?

The FDA product code for TRIGEN META-TAN Trochanteric Antegrade Nail is HSB.

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