FDA.reportPublic FDA data

Materialise Ukraine, Rep. office

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095554403009555440Materialise Ukraine, Rep. office1N2026-01-01Raisy Okipnoy str., 8A Kyiv Kyyiv, Misto UA 02002

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1395171687114807K253793Materialise TKA Guide SystemJWH2026-01-06
1395171881321831K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsPPT2026-01-07
1395171648626710K251964Mimics Thoracic PlannerLLZ2026-03-12
1395171347529537K251554Materialise TKA Guide SystemJWH2025-07-14
1395171292852037K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ2025-02-21
1395171629518160K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-10-18
1395171358777051K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-05-22
1395171722410129K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2023-11-09
1395171001029523K233217Mimics Cardiac PlannerLLZ2024-02-12
1395171055088897K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2023-09-12
1395171468238354K230315Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHE2023-03-06
1395171287934806K223427Mimics Enlight CMFLLZ2024-05-31
1395171040878518K221337Materialise TKA Guide SystemJWH2022-07-05
1395171207946287K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHE2022-08-17
1395171112452059K213684SurgiCase ViewerLLZ2022-06-15
1395171431307421K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2022-01-12
1395171776229984K202207Materialise PKA Guide SystemHSX2020-10-02
1395171060352406K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerQHE2020-03-20
1395171526366082K190874Materialise Mimics EnlightLLZ2019-06-05
1395171609297469K190286Materialise Glenoid Positioning SystemKWS2019-07-08
1395171652996576K183105Mimics MedicalLLZ2019-03-27
1395171781074907K173970Materialise PKA Guide SystemHSX2018-07-06
1395171860212778K173445Materialise TKA Guide SystemJWH2018-02-02
1395171276925818K173039TruMatch CMF Titanium 3D Printed ImplantJEY2018-07-10
1395171914173473K172650Materialise PKA Guide SystemHSX2017-11-20
1395171388088088K172054Materialise Glenoid Positioning SystemKWS2017-11-03
1395172071211074K170893Materialise Glenoid Positioning SystemKWS2017-06-19
1395171547390648K170272TruMatch CMF Titanium 3D Printed Implant SystemJEY2017-08-08
1395171326359165K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesPBF2017-01-18
1395171383155258K162273Materialise TKA Guide SystemJWH2016-11-07
1395171729657684K153602Materialise Glenoid Positioning SystemKWS2016-04-26
1395171511725520K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesJWH2015-08-10
1395171559139031K140257SIGNATURE PLANNER, SIGNATURE GUIDESMBH2014-04-02
1395171111522869K140027ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNERJWH2014-05-22
1395171460775197K133162ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLAJWH2014-02-25
1395171525328349K132290SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDESPBF2014-04-10
1395171088400091K131559MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDESKWS2013-09-27
1395171043731831K121640ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEMJWH2012-12-05
1395171222780485K113829ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNEJWH2012-04-02
1395171117931285K112301ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNERHSX2012-01-06
1395171023234674K111492ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTSJWH2011-10-13
1395171903702377K110415SIGNATURE PLANNER / SIGNATURE GUIDESHRY2011-05-16
1395171954290267K102795SIGNATURE PLANNER; SIGNATURE GUIDESJWH2011-02-02
1395171028644657K093533ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0MBH2010-02-17
1395171920212394K091263ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)JWH2009-11-19
1395171839756374K073468MIMICSLLZ2008-04-02
1395171008950202
1395171352353689

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH132026-01-06
QHE82024-10-18
LLZ72026-03-12
KWS52019-07-08
HSX42020-10-02
JEY22018-07-10
PBF22017-01-18
MBH22014-04-02
PPT12026-01-07
DZJ12025-02-21
HRY12011-05-16