MedCAD® AccuPlan® System

Driver, Wire, And Bone Drill, Manual

MedCAD

The following data is part of a premarket notification filed by Medcad with the FDA for Medcad® Accuplan® System.

Pre-market Notification Details

Device IDK192282
510k NumberK192282
Device Name:MedCAD® AccuPlan® System
ClassificationDriver, Wire, And Bone Drill, Manual
Applicant MedCAD 501 2nd Ave, Suite A-1000 Dallas,  TX  75226
ContactBrian Buss
CorrespondentLinda Braddon
Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock,  GA  30188
Product CodeDZJ  
CFR Regulation Number872.4120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2020-10-29

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