Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021635140

FEI Number

3021635140

Entity Name

MedCAD

City/State/Country

Plano, TX, US

Establishment Address

3401 Technology Dr, Unit 3, Plano, TX 75074, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MedCAD (Owner Number: 10037478)

Owner / Operator Contact Address

501 Second Ave., Suite A-1000, Dallas, TX 75226, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K220357

PMA Number

N/A

All Registered Proprietary Names

AccuPlate 3DTi Patient-Specific Plating System AccuPlan System 3DTi AccuPlan System Orthopedics AccuShape MedCAD® AccuStride System AccuPlate AccuPlate Patient-Specific Plate MedCAD® AccuStride System AccuShape Titanium Patient-Specific Cranial Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2021-07-20
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2021-07-20
JEY	Plate, Bone	Dental	Class 2	872.4760	2023-09-27
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-09-21
DZJ	Driver, Wire, And Bone Drill, Manual	Dental	Class 2	872.4120	2023-09-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-09-21
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2023-09-21
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2011-07-18
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2026-01-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-01-28
JEY	Plate, Bone	Dental	Class 2	872.4760	2021-08-30
PBF	Orthopaedic Surgical Planning And Instrument Guides	Orthopedic	Class 2	888.3030	2025-03-14
GXN	Plate, Cranioplasty, Preformed, Non-Alterable	Neurology	Class 2	882.5330	2022-08-31

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MedCAD

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3009196021	VanDuzen, Inc. dba MedCAD	Dallas, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31
K122260	Aycan Digitalsysteme GmbH	AYCAN MOBILE	2012-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3007997036	STRYKER MANUFACTURING KALAMAZOO	Portage, MI, US
3033509898	STRAITS ORTHOPAEDICS (MFG) SDN BHD	Bandar Cassia Pulau Pinang, MY
1057946	KLS-Martin L.P.	Jacksonville, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021635140. Last updated year: 2026. Please use registration number 3021635140 when referencing this establishment in official correspondence.