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FDA 510(k)

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

N.º K: K193560 · 2020-03-20

SolicitanteMaterialise NV
Fecha de decisión2020-03-20
Código de productoQHE
Comité asesorOR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase 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 2020-03-20 under 510(k) number K193560. 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 Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner?

Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is Materialise NV. The 510(k) number is K193560.

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

Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner received FDA 510(k) clearance on 2020-03-20, under 510(k) number K193560.

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

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

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Otros registros que enlistan a Materialise NV como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Dispositivos relacionados (Código: QHE)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NVK261510Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.K243509Sistema PSI Archer3D-SideK241470CORE 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.

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