FDA 510(k)

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner

N.º K: K212569 · 2022-01-12

Fecha de decisión2022-01-12

Código de productoQHE

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is the device name listed in this FDA 510(k) record. The listed applicant is Materialise NV. It received FDA 510(k) clearance on 2022-01-12 under 510(k) number K212569. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is a medical device that received FDA 510(k) clearance on 2022-01-12. The listed applicant is Materialise NV. The 510(k) number is K212569.

When did Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner receive FDA 510(k) clearance?

Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner received FDA 510(k) clearance on 2022-01-12, under 510(k) number K212569.

Who is the listed applicant for Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

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

What is the FDA product code for Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner?

The FDA product code for Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner is QHE.

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Otros registros que enlistan a Materialise NV como solicitante

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K251964Mimics Thoracic Planner K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic Models K253793Materialise TKA Guide System K251554Materialise TKA Guide System K243637Materialise Personalized Guides and Models for Craniomaxillofacial Surgery

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Dispositivos relacionados (Código: QHE)

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NV K261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS K260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CAS K251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.K243509Sistema PSI Archer3D-Side K241470CORE Shoulder SystemLinkBio Corp.

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.