Data / Medical devices / United States / MedCAD

MedCAD: FDA-registered device maker in Plano, TX, United States, 9 510(k) clearances

Name: MedCAD FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

MedCAD is registered with the FDA (registration 3021635140) in Plano, TX, United States. It lists 6 device types. The FDA files 9 510(k) clearances under its listings, the newest dated November 4, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3021635140
Address: 3401 Technology Dr Unit 3, Plano, TX, United States, 75074
Owner or operator: MedCAD (10037478)
Roles: Manufacturer
First device listed: July 18, 2011
Registered through: 2026
Brand names listed: AccuPlan System 3DTi, AccuPlan System Orthopedics, AccuPlate, AccuPlate 3DTi Patient-Specific Plating System, AccuPlate Patient-Specific Plate, AccuShape, AccuShape Titanium Patient-Specific Cranial Implant, MedCAD® AccuStride System

Devices it lists

Device	Product code	Class	Role	Source
Driver, Wire, And Bone Drill, Manual	DZJ	2	Manufacturer	accessdata.fda.gov
Orthopaedic Surgical Planning And Instrument Guides	PBF	2	Manufacturer	accessdata.fda.gov
Plate, Bone	JEY	2	Manufacturer	accessdata.fda.gov
Plate, Cranioplasty, Preformed, Non-Alterable	GXN	2	Manufacturer	accessdata.fda.gov
Plate, Fixation, Bone	HRS	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 4, 2025	K251709	MedCAD® AccuStride System	PBF	Substantially Equivalent	Medcad	accessdata.fda.gov
March 13, 2025	K241811	MedCAD® AccuStride System	PBF	Substantially Equivalent	Medcad	accessdata.fda.gov
September 26, 2023	K230398	MedCAD® AccuPlate® 3DTi Patient-Specific Plating System	JEY	Substantially Equivalent	Medcad	accessdata.fda.gov
September 20, 2023	K223421	MedCAD AccuPlan Orthopedics System	PBF	Substantially Equivalent	Medcad	accessdata.fda.gov
March 7, 2023	K223024	MedCAD AccuPlan System	DZJ	Substantially Equivalent	Medcad	accessdata.fda.gov
August 26, 2022	K220357	MedCAD AccuShape Titanium Patient-Specific Cranial Implant	GXN	Substantially Equivalent	Medcad	accessdata.fda.gov
February 12, 2021	K193280	MedCAD® AccuPlate® Patient-Specific Plate	JEY	Substantially Equivalent	Medcad	accessdata.fda.gov
October 29, 2020	K192282	MedCAD® AccuPlan® System	DZJ	Substantially Equivalent	Medcad	accessdata.fda.gov
June 24, 2011	K110684	MEDCAD ACCUSHAPE (TM) PEEK PATIENT SPECIFIC CRANIAL / CRANIOFACIAL IMPLANT	GXN	Substantially Equivalent	Vanduzen Dba Medcad	accessdata.fda.gov

Compare with other makers

Updated November 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.