510(k) K230398

MedCAD® AccuPlate® 3DTi Patient-Specific Plating System by Medcad — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2023
Date Received
February 16, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type