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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 the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2020-10-29 under 510(k) 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. The listed applicant is Medcad. The 510(k) number is K192282.

When did MedCAD® AccuPlan® System receive FDA 510(k) clearance?

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

Who is the listed applicant for MedCAD® AccuPlan® System?

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® AccuPlan® System?

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

Other records listing Medcad as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252064MedCAD® AccuStride™ SystemK251709MedCAD® AccuStride™ SystemK241811MedCAD® AccuStride™ SystemK230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemK223421MedCAD AccuPlan Orthopedics SystemK223024MedCAD AccuPlan System

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Related Devices (Code: DZJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261826VSP System (Titanium Palatal Splint)3D Systems, Inc.K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NVK242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.K231520tmCMF SolutionTechmah CmfK230276TECHFIT DISRP® SystemTechfit Digital SurgeryK223024MedCAD AccuPlan SystemMedcad

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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