FDA.reportPublic FDA data

MedCAD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30216351403021635140MedCAD1N2026-01-013401 Technology Dr Unit 3 Plano TX US 75074

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00810007633343AccuPlan System - ANATOMICAL MODEL, STERNUM(214) 453-8864support@medcad.com
00810007633350AccuPlan System - ANATOMICAL MODEL, RIBCAGE(214) 453-8864support@medcad.com
00810007633398AccuStride System - 3D Printed Titanium Plate, Small(214) 453-8864support@medcad.net
00810007633404AccuStride System - 3D Printed Titanium Plate, Large(214) 453-8864support@medcad.net
00810007633411AccuStride System - Surgical Planning Kit W/ Custom Pt. Specific Implant and Guide Bundle Tier 1(214) 453-8864support@medcad.net
00810007633428AccuStride System - Surgical Planning Kit W/ Custom Pt. Specific Implants and Guides Bundle Tier 2(214) 453-8864support@medcad.net

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3026121263297216K251709MedCAD® AccuStride™ SystemPBF2025-11-04
3026121886940696K241811MedCAD® AccuStride™ SystemPBF2025-03-13
3026121735978001K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemJEY2023-09-26
3026121857383199K223421MedCAD AccuPlan Orthopedics SystemPBF2023-09-20
3026121243757150K223024MedCAD AccuPlan SystemDZJ2023-03-07
3026121621166378K220357MedCAD AccuShape Titanium Patient-Specific Cranial ImplantGXN2022-08-26
3026121844162625K193280MedCAD® AccuPlate® Patient-Specific PlateJEY2021-02-12
3026121746594712K192282MedCAD® AccuPlan® SystemDZJ2020-10-29
3026121773571918K110684MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANTGXN2011-06-24

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

PMN#

GUDID#

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