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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K230398
Device Name MedCAD® AccuPlate® 3DTi Patient-Specific Plating System
Applicant
Medcad
501 S 2nd Ave.
Suite A-1000
Dallas,  TX  75226
Applicant Contact Brian Buss
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Justin Gracyalny
Regulation Number872.4760
Classification Product Code
JEY  
Date Received02/16/2023
Decision Date 09/26/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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