FDA 510(k)

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System

K-Number: K230398 · 2023-09-26

ApplicantMedcad

Decision Date2023-09-26

Product CodeJEY

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Medcad. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K230398. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is Medcad. The 510(k) number is K230398.

When did MedCAD® AccuPlate® 3DTi Patient-Specific Plating System receive FDA 510(k) clearance?

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System received FDA 510(k) clearance on 2023-09-26, under 510(k) number K230398.

Who is the listed applicant for MedCAD® AccuPlate® 3DTi Patient-Specific Plating 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® AccuPlate® 3DTi Patient-Specific Plating System?

The FDA product code for MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is JEY.

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.

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Related Devices (Code: JEY)

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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.