FDA 510(k)

United U2 femoral head, 22mm delta ceramic head

N.º K: K221675 · 2022-11-04

SolicitanteUnited Orthopedic Corporation

Fecha de decisión2022-11-04

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a United Orthopedic Corporation como solicitante

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Fuente oficial

Ver en la base de datos de la FDA →

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