FDA 510(k)

United U2 femoral head, 22mm delta ceramic head

Número K: K221675 · 2022-11-04

Data da decisão2022-11-04

Código do produtoLPH

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

United U2 femoral head, 22mm delta ceramic head is the device name listed in this FDA 510(k) record. The listed applicant is United Orthopedic Corporation. It received FDA 510(k) clearance on 2022-11-04 under 510(k) number K221675. 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 United U2 femoral head, 22mm delta ceramic head?

United U2 femoral head, 22mm delta ceramic head is a medical device that received FDA 510(k) clearance on 2022-11-04. The listed applicant is United Orthopedic Corporation. The 510(k) number is K221675.

When did United U2 femoral head, 22mm delta ceramic head receive FDA 510(k) clearance?

United U2 femoral head, 22mm delta ceramic head received FDA 510(k) clearance on 2022-11-04, under 510(k) number K221675.

Who is the listed applicant for United U2 femoral head, 22mm delta ceramic head?

The FDA 510(k) record lists United Orthopedic Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for United U2 femoral head, 22mm delta ceramic head?

The FDA product code for United U2 femoral head, 22mm delta ceramic head is LPH.

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Outros registros que listam United Orthopedic Corporation como candidato(a)

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Fonte oficial

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