FDA 510(k)

Escalade Legend Acetabular Shell

N.º K: K161080 · 2016-05-17

SolicitanteOrtho Development Corporation

Fecha de decisión2016-05-17

Código de productoLPH

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Escalade Legend Acetabular Shell is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Development Corporation. It received FDA 510(k) clearance on 2016-05-17 under 510(k) number K161080. 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 Escalade Legend Acetabular Shell?

Escalade Legend Acetabular Shell is a medical device that received FDA 510(k) clearance on 2016-05-17. The listed applicant is Ortho Development Corporation. The 510(k) number is K161080.

When did Escalade Legend Acetabular Shell receive FDA 510(k) clearance?

Escalade Legend Acetabular Shell received FDA 510(k) clearance on 2016-05-17, under 510(k) number K161080.

Who is the listed applicant for Escalade Legend Acetabular Shell?

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

What is the FDA product code for Escalade Legend Acetabular Shell?

The FDA product code for Escalade Legend Acetabular Shell is LPH.

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Fuente oficial

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