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
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
00810007633329AccuStride System MC-STP001MC-STP0012025-08-25
00810007633282AccuStride System MC-3D132MC-3D1322025-06-30
00810007633299AccuStride System MC-3D133MC-3D1332025-06-30
00810007633305AccuStride System MC-3D134MC-3D1342025-06-30
00810007633312AccuStride System MC-3D131MC-3D1312025-06-30
00810007633244AccuStride System MC-KST000MC-KST0002025-06-10
00081000763324AccuStride System MC-KST000MC-KST0002025-05-05
00810007632889AccuPlan System MC-KTP130-H2024-10-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
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17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08437021468175QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2025-07-04
07630542730153MyShoulder PlannerMedacta International SALLZ2025-02-06
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
07613252286622FLUOROMAPStryker Leibinger GmbH & Co. KGLLZ2025-01-28
08056304455727G-scan OpenESAOTE SPALLZ2024-07-02
08056600520044Nical Flat PanelNICAL SPALLZ2023-10-09
07630345779939NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797063NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797070NextAR Spine Platform Medacta International SAPBF2023-07-24
07630345797087NextAR Spine Platform Medacta International SAPBF2023-07-24
G221200CA3080iQ ViewFirst Source, Inc.LLZ2023-06-13
07630542715679Advanced MyHip PlannerMedacta International SALLZ2023-01-26
07630030855818MyHip bone modelMedacta International SALLZ2023-01-23
07630030855825MyHip bone modelMedacta International SALLZ2023-01-23
07630030855832MyHip bone modelMedacta International SALLZ2023-01-23
07630030855849MyHip bone modelMedacta International SALLZ2023-01-23
07630345729286Advanced MyHip PlannerMedacta International SALLZ2023-01-23
G2710300240140IntelliguidesMios Marketing, LLCPBF2023-01-01