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FDA 510(k)

MedCAD® AccuPlate® Patient-Specific Plate

K-Number: K193280 · 2021-02-12

ApplicantMedcad
Decision Date2021-02-12
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MedCAD® AccuPlate® Patient-Specific Plate is a medical device manufactured by Medcad. It received FDA 510(k) clearance on 2021-02-12 under approval number K193280. 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® Patient-Specific Plate?

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

When was MedCAD® AccuPlate® Patient-Specific Plate approved by the FDA?

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

What company makes MedCAD® AccuPlate® Patient-Specific Plate?

MedCAD® AccuPlate® Patient-Specific Plate is manufactured by Medcad.

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 42014629 Clinical implementation of an EU MDR-compliant point-of-care manufacturing framework for patient-specific 3D-printed PEEK implants in craniomaxillofacial reconstruction. 3D printing in medicine (2026) PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41770469 Use and regulation of patient-specific three-dimensional printing in medicine: a survey of physician end-users. 3D printing in medicine (2026) PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026)

Other Devices by Medcad

K192282MedCAD® AccuPlan® System K220357MedCAD AccuShape Titanium Patient-Specific Cranial Implant K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating System K223421MedCAD AccuPlan Orthopedics System K223024MedCAD AccuPlan System K251709MedCAD® AccuStride™ System

View all 9 devices →

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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.

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