FDA 510(k)

Platform® Acetabular System

N.º K: K220483 · 2022-09-23

SolicitanteTotal Joint Orthopedics, Inc.

Fecha de decisión2022-09-23

Código de productoLZO

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Platform® Acetabular System is the device name listed in this FDA 510(k) record. The listed applicant is Total Joint Orthopedics, Inc.. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K220483. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Platform® Acetabular System?

Platform® Acetabular System is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is Total Joint Orthopedics, Inc.. The 510(k) number is K220483.

When did Platform® Acetabular System receive FDA 510(k) clearance?

Platform® Acetabular System received FDA 510(k) clearance on 2022-09-23, under 510(k) number K220483.

Who is the listed applicant for Platform® Acetabular System?

The FDA 510(k) record lists Total Joint Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Platform® Acetabular System?

The FDA product code for Platform® Acetabular System is LZO.

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Fuente oficial

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