MedCAD® AccuPlate® Patient-Specific Plate
FDA 510(k) K193280 · Medcad
510(k) numberK193280
Submission
- Device name
- MedCAD® AccuPlate® Patient-Specific Plate
- Applicant
- Medcad
Dallas, TX, US - Received
- November 27, 2019
- Decision date
- February 12, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MedCAD® AccuPlate® Patient-Specific Plate cleared by the FDA?
MedCAD® AccuPlate® Patient-Specific Plate (K193280) received a 510(k) decision of Substantially Equivalent on February 12, 2021, 443 days after the submission was received.
What is the product code of K193280?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.