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 a medical device manufactured by Medcad. It received FDA 510(k) clearance on 2023-09-26 under approval 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. It is manufactured by Medcad. The 510(k) number is K230398.
When was MedCAD® AccuPlate® 3DTi Patient-Specific Plating System approved by the FDA?
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System received FDA 510(k) clearance on 2023-09-26, under approval number K230398.
What company makes MedCAD® AccuPlate® 3DTi Patient-Specific Plating System?
MedCAD® AccuPlate® 3DTi Patient-Specific Plating System is manufactured by Medcad.
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.
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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.