FDA.reportPublic FDA data

SurgiCase

Primary DI
E314SURGICASECONNECT0
Brand
SurgiCase
Company
Materialise NV
Model
SurgiCase Connect
Catalog number
SurgiCase Connect
Device description
SurgiCase Connect
Published
2017-02-10
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PBFOrthopaedic Surgical Planning And Instrument Guides

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBFOrthopaedic Surgical Planning And Instrument GuidesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132290000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132290000SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDESMaterialise NV2014-04-10PBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E314SURGICASECONNECT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
CAD/CAM softwareA software program intended to provide computer-aided design (CAD) or computer-aided manufacturing (CAM) functionality for the production of patient-specific custom-made devices (e.g., orthopaedic implants, dental devices, anatomical models), treatment planning, simulation, and/or robotic capabilities for device production (e.g., 3-D printing).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
373139427
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E31442100200Signature42-10020042-1002002026-09-24
E31442100300Signature42-10030042-1003002026-09-24
E31442411410Signature42-41141042-4114102026-09-24
E31442422415Signature42-42241542-4224152026-09-24
E31442422450Signature42-42245042-4224502026-09-24
E31442422451Signature42-42245142-4224512026-09-24
E31442422452Signature42-42245242-4224522026-09-24
E31442422453Signature42-42245342-4224532026-09-24
E31442422455Signature42-42245542-4224552026-09-24
E31442422456Signature42-42245642-4224562026-09-24
E31442422457Signature42-42245742-4224572026-09-24
E31442422458Signature42-42245842-4224582026-09-24
E31442422460Signature42-42246042-4224602026-09-24
E31442422461Signature42-42246142-4224612026-09-24
E31442422462Signature42-42246242-4224622026-09-24
E31442422463Signature42-42246342-4224632026-09-24
E31442422465Signature42-42246542-4224652026-09-24
E31442422466Signature42-42246642-4224662026-09-24
E31442422467Signature42-42246742-4224672026-09-24
E31442422468Signature42-42246842-4224682026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00688346005356Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005387Fine Osteotomy System - Femoral plateLaboratoires Bodycad IncPBF2026-08-03
00688346005523Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00688346005554Fine Osteotomy System - Tibial plateLaboratoires Bodycad IncPBF2026-08-03
00885556925379CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
00885556925386CORIOGRAPHSmith & Nephew, Inc.PBF2026-07-08
054005500102173D-CUT3D-SidePBF2026-04-28
054005501506163D-CUT3D-SidePBF2026-04-28
054005501506233D-CUT3D-SidePBF2026-04-28
054005501506303D-CUT3D-SidePBF2026-04-28
054005501506473D-CUT3D-SidePBF2026-04-28
054005501506543D-CUT3D-SidePBF2026-04-28
054005501506613D-CUT3D-SidePBF2026-04-28
00840124525542FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525559FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525566FuzeFix LargeFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124525597FuzeFix LargeFUSION ORTHOPEDICS, LLCPBF2026-04-23
00840124516779FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00840124517783FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00840124525467FibFixFUSION ORTHOPEDICS, LLCPBF2026-04-09
00860009815780EmbedMed3D LIFEPRINTS UK LTDPBF2026-03-30
00840124521773PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521780PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521797PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521803PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521810PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521827PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521834PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02
00840124521841PolyLock MidfootFUSION ORTHOPEDICS, LLCPBF2025-10-02