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FDA 510(k)

MedCAD® AccuPlan® System

K-Number: K192282 · 2020-10-29

ApplicantMedcad
Decision Date2020-10-29
Product CodeDZJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MedCAD® AccuPlan® System is a medical device manufactured by Medcad. It received FDA 510(k) clearance on 2020-10-29 under approval number K192282. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MedCAD® AccuPlan® System?

MedCAD® AccuPlan® System is a medical device that received FDA 510(k) clearance on 2020-10-29. It is manufactured by Medcad. The 510(k) number is K192282.

When was MedCAD® AccuPlan® System approved by the FDA?

MedCAD® AccuPlan® System received FDA 510(k) clearance on 2020-10-29, under approval number K192282.

What company makes MedCAD® AccuPlan® System?

MedCAD® AccuPlan® System is manufactured by Medcad.

What is the FDA product code for MedCAD® AccuPlan® System?

The FDA product code for MedCAD® AccuPlan® System is DZJ.

Other Devices by Medcad

K193280MedCAD® AccuPlate® Patient-Specific Plate K220357MedCAD AccuShape Titanium Patient-Specific Cranial Implant K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating System K223421MedCAD AccuPlan Orthopedics System K223024MedCAD AccuPlan System K251709MedCAD® AccuStride™ System

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Related Devices (Code: DZJ)

K181241KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. K172164PROPEL DevicePropel Orthodontics, LLC K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P. K193499DigiGuide SystemProtomed, Inc. K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch K192192VSP System3D Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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