FDA 510(k)

Southern Craniomaxillofacial (CMF) System

N.º K: K253373 · 2025-12-19

SolicitanteSouthern Medical (Pty) , Ltd.

Fecha de decisión2025-12-19

Código de productoJEY

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Southern Craniomaxillofacial (CMF) System is the device name listed in this FDA 510(k) record. The listed applicant is Southern Medical (Pty) , Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K253373. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Southern Craniomaxillofacial (CMF) System?

Southern Craniomaxillofacial (CMF) System is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Southern Medical (Pty) , Ltd.. The 510(k) number is K253373.

When did Southern Craniomaxillofacial (CMF) System receive FDA 510(k) clearance?

Southern Craniomaxillofacial (CMF) System received FDA 510(k) clearance on 2025-12-19, under 510(k) number K253373.

Who is the listed applicant for Southern Craniomaxillofacial (CMF) System?

The FDA 510(k) record lists Southern Medical (Pty) , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Southern Craniomaxillofacial (CMF) System?

The FDA product code for Southern Craniomaxillofacial (CMF) System is JEY.

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Dispositivos relacionados (Código: JEY)

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.