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FDA 510(k)

Placas de Malla de Bloqueo 3D Personalizadas para Pacientes de Ortodoncia Additive Orthopaedics

N.º K: K183011 · 2019-01-10

SolicitanteAdditive Orthopaedics
Fecha de decisión2019-01-10
Código de productoHRS
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is the device name listed in this FDA 510(k) record. The listed applicant is Additive Orthopaedics. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K183011. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Additive Orthopaedics Patient Specific 3D Locking Lattice Plates?

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is Additive Orthopaedics. The 510(k) number is K183011.

When did Additive Orthopaedics Patient Specific 3D Locking Lattice Plates receive FDA 510(k) clearance?

Additive Orthopaedics Patient Specific 3D Locking Lattice Plates received FDA 510(k) clearance on 2019-01-10, under 510(k) number K183011.

Who is the listed applicant for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates?

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

What is the FDA product code for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates?

The FDA product code for Additive Orthopaedics Patient Specific 3D Locking Lattice Plates is HRS.

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Fuente oficial

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

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