FDA.reportPublic FDA data

Materialise USA, LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057188163005718816Materialise USA, LLC.1Y2026-01-0144650 Helm Court Plymouth MI US 48170

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1201551687114807K253793Materialise TKA Guide SystemJWH2026-01-06
1201551881321831K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsPPT2026-01-07
1201551347529537K251554Materialise TKA Guide SystemJWH2025-07-14
1201551292852037K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ2025-02-21
1201551629518160K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-10-18
1201551358777051K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-05-22
1201551722410129K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2023-11-09
1201551055088897K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2023-09-12
1201551468238354K230315Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHE2023-03-06
1201551040878518K221337Materialise TKA Guide SystemJWH2022-07-05
1201551207946287K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHE2022-08-17
1201551431307421K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2022-01-12
1201551776229984K202207Materialise PKA Guide SystemHSX2020-10-02
1201551060352406K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerQHE2020-03-20
1201551609297469K190286Materialise Glenoid Positioning SystemKWS2019-07-08
1201551781074907K173970Materialise PKA Guide SystemHSX2018-07-06
1201551587492633K173619Mimics inPrintLLZ2018-03-21
1201551860212778K173445Materialise TKA Guide SystemJWH2018-02-02
1201551276925818K173039TruMatch CMF Titanium 3D Printed ImplantJEY2018-07-10
1201551914173473K172650Materialise PKA Guide SystemHSX2017-11-20
1201551388088088K172054Materialise Glenoid Positioning SystemKWS2017-11-03
1201552071211074K170893Materialise Glenoid Positioning SystemKWS2017-06-19
1201551547390648K170272TruMatch CMF Titanium 3D Printed Implant SystemJEY2017-08-08
1201551326359165K163156SurgiCase Orthopaedics, SurgiCase Connect, SurgiCase GuidesPBF2017-01-18
1201551383155258K162273Materialise TKA Guide SystemJWH2016-11-07
1201551729657684K153602Materialise Glenoid Positioning SystemKWS2016-04-26
1201551511725520K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesJWH2015-08-10
1201551559139031K140257SIGNATURE PLANNER, SIGNATURE GUIDESMBH2014-04-02
1201551111522869K140027ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNERJWH2014-05-22
1201551460775197K133162ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLAJWH2014-02-25
1201551525328349K132290SURGICASE ORTHOPAEDICS SYSTEM, SURGICASE CONNECT, SURGICASE GUIDESPBF2014-04-10
1201551088400091K131559MATCH POINT SYSTEM(TM), SURGICASE CONNECT, MATCH POINT SYSTEM(TM) GUIDESKWS2013-09-27
1201551043731831K121640ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEMJWH2012-12-05
1201551222780485K113829ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNEJWH2012-04-02
1201551784837376K112389SURGICASE CONNECT, SURGICASE GUIDEPBF2012-07-20
1201551117931285K112301ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNERHSX2012-01-06
1201551687131810K111863SIGNATURE PLANNER,SIGNATURE GUIDESJDI2012-06-15
1201551869621061K111558SURGICASE GUIDEHAW2012-03-27
1201551023234674K111492ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTSJWH2011-10-13
1201551903702377K110415SIGNATURE PLANNER / SIGNATURE GUIDESHRY2011-05-16
1201551898256055K103136SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDEJEY2011-03-18
1201551954290267K102795SIGNATURE PLANNER; SIGNATURE GUIDESJWH2011-02-02
1201551028644657K093533ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0MBH2010-02-17
1201551920212394K091263ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)JWH2009-11-19
1201551661392545
1201551214579185
1201551574967996
1201551813040094
1201551993315711

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH132026-01-06
QHE82024-10-18
KWS52019-07-08
HSX42020-10-02
JEY32018-07-10
PBF32017-01-18
MBH22014-04-02
PPT12026-01-07
DZJ12025-02-21
LLZ12018-03-21
JDI12012-06-15
HAW12012-03-27
HRY12011-05-16

GUDID#