FDA.reportPublic FDA data

AccuModel

Primary DI
00810007633275
Brand
AccuModel
Company
Medcad
Model
MC-3D131
Catalog number
MC-3D131
Device description
ANATOMICAL MODEL, FOOT & ANKLE
Published
2025-05-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810007633275PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810007633275008100076332758100076332750810007633275

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made organ/bone anatomy modelA model of an organ (e.g., heart, kidney, lung) or bone of a specific patient intended to be used to assist anatomical visualization and surgical treatment planning. It is created using additive (three-dimensional [3-D] printing) processes based on patient medical images. It is typically made of a synthetic polymer, marked with a unique identifier.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(214) 453-8864support@medcad.net

Regulatory Flags#

DUNS number
144723868
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810007633282AccuStride SystemMC-3D132MC-3D1322025-06-30
00810007633299AccuStride SystemMC-3D133MC-3D1332025-06-30
00810007633305AccuStride SystemMC-3D134MC-3D1342025-06-30
00810007633312AccuStride SystemMC-3D131MC-3D1312025-06-30
00810007633244AccuStride SystemMC-KST000MC-KST0002025-06-10
00081000763324AccuStride SystemMC-KST000MC-KST0002025-05-05
00810007633251AccuStride SystemMC-KST000-RMC-KST000-R2025-05-05
00810007633268AccuStride SystemMC-KST001MC-KST0012025-05-05
00810007633442AccuStride System MC-KSP003MC-KSP0032026-02-20
00810007633398AccuStride System MC-STP001MC-STP0012026-02-04
00810007633404AccuStride System MC-STP002MC-STP0022026-02-04
00810007633411AccuStride System MC-KSP000MC-KSP0002026-02-04
00810007633428AccuStride System MC-KSP001MC-KSP0012026-02-04
00810007633435AccuStride System MC-KSP002MC-KSP0022026-02-04
00810007633343AccuPlan SystemMC-3D217MC-3D2172025-10-31
00810007633350AccuPlan SystemMC-3D218MC-3D2182025-10-31
00810007633367AccuPlan SystemZB-3D217ZB-3D2172025-10-31
00810007633374AccuPlan SystemZB-3D218ZB-3D2182025-10-31
00810007633381AccuPlan SystemZB-KFITZB-KFIT2025-10-31
00810007633336AccuPlan System MC-KFITMC-KFIT2025-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00810007633282AccuStride SystemMedcadPBF2025-06-30
00810007633299AccuStride SystemMedcadPBF2025-06-30
00810007633305AccuStride SystemMedcadPBF2025-06-30
00810007633312AccuStride SystemMedcadPBF2025-06-30
00810007633244AccuStride SystemMedcadPBF2025-06-10
00810111224680TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2025-05-22
00810111224697TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2025-05-22
00081000763324AccuStride SystemMedcadPBF2025-05-05
00810007633251AccuStride SystemMedcadPBF2025-05-05
00810007633268AccuStride SystemMedcadPBF2025-05-05
00198715251623BrainSpec Core™ SoftwareBrainSpec Inc.LLZ2025-02-10
00670082000610Modus PlanSynaptive Medical IncLLZ2025-01-17
00810111223553TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223560TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223577TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223584TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-15
00810111223447TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223454TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223478TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00810111223621TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-11-14
00195278753472ViewPointGE Healthcare GmbHLLZ2024-07-15
00810111222723TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-03-11
00810111222730TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2024-03-11
00810111222259TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2023-11-17
00810111222266TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2023-11-17
00810111222273TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2023-11-17
00810111222280TMC PSI Cut Guide SystemTreace Medical Concepts, Inc.PBF2023-11-17