FDA 510(k)

EMPHASYS Acetabular Shell with RapiTite HA

Número K: K242084 · 2024-10-07

Data da decisão2024-10-07

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

EMPHASYS Acetabular Shell with RapiTite HA is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2024-10-07 under 510(k) number K242084. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EMPHASYS Acetabular Shell with RapiTite HA?

EMPHASYS Acetabular Shell with RapiTite HA is a medical device that received FDA 510(k) clearance on 2024-10-07. The listed applicant is Depuy Ireland UC. The 510(k) number is K242084.

When did EMPHASYS Acetabular Shell with RapiTite HA receive FDA 510(k) clearance?

EMPHASYS Acetabular Shell with RapiTite HA received FDA 510(k) clearance on 2024-10-07, under 510(k) number K242084.

Who is the listed applicant for EMPHASYS Acetabular Shell with RapiTite HA?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMPHASYS Acetabular Shell with RapiTite HA?

The FDA product code for EMPHASYS Acetabular Shell with RapiTite HA is LPH.

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