FDA 510(k)

MedCAD® AccuPlate® Patient-Specific Plate

N.º K: K193280 · 2021-02-12

SolicitanteMedcad

Fecha de decisión2021-02-12

Código de productoJEY

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

MedCAD® AccuPlate® Patient-Specific Plate is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K193280. 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 MedCAD® AccuPlate® Patient-Specific Plate?

MedCAD® AccuPlate® Patient-Specific Plate is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is Medcad. The 510(k) number is K193280.

When did MedCAD® AccuPlate® Patient-Specific Plate receive FDA 510(k) clearance?

MedCAD® AccuPlate® Patient-Specific Plate received FDA 510(k) clearance on 2021-02-12, under 510(k) number K193280.

Who is the listed applicant for MedCAD® AccuPlate® Patient-Specific Plate?

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

What is the FDA product code for MedCAD® AccuPlate® Patient-Specific Plate?

The FDA product code for MedCAD® AccuPlate® Patient-Specific Plate is JEY.

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Otros registros que enlistan a Medcad como solicitante

K252064MedCAD® AccuStride™ System K251709MedCAD® AccuStride™ System K241811MedCAD® AccuStride™ System K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating System K223421MedCAD AccuPlan Orthopedics System K223024MedCAD AccuPlan System

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Dispositivos relacionados (Código: JEY)

K260137KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient SolutionsKLS-Martin L.P.K253206METICULY Patient-specific CMF solutionMeticuly Co., Ltd.K252246Leforte MMF SystemJeil Medical Corporation K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.

Fuente oficial

Ver en la base de datos de la FDA →

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