FDA.reportPublic FDA data

VanDuzen, Inc. dba MedCAD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091960213009196021VanDuzen, Inc. dba MedCAD1N2026-01-01501 S 2nd Ave Ste A1000 Dallas TX US 75226

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1310851263297216K251709MedCAD® AccuStride™ SystemPBF2025-11-04
1310851886940696K241811MedCAD® AccuStride™ SystemPBF2025-03-13
1310851735978001K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemJEY2023-09-26
1310851857383199K223421MedCAD AccuPlan Orthopedics SystemPBF2023-09-20
1310851243757150K223024MedCAD AccuPlan SystemDZJ2023-03-07
1310851621166378K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantGXN2022-08-26
1310851844162625K193280MedCAD® AccuPlate® Patient-Specific PlateJEY2021-02-12
1310851746594712K192282MedCAD® AccuPlan® SystemDZJ2020-10-29
1310851773571918K110684MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANTGXN2011-06-24
1310851278805485
1310851101085324
1310852051087019

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PBF32025-11-04
JEY22023-09-26
DZJ22023-03-07
GXN22022-08-26