FDA.reportPublic FDA data

Jenny Jones

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095554473009555447Jenny Jones1N2026-01-0144650 Helm Court Plymouth MI US 48170
30117245823011724582Jenny Jones1N2026-01-0144650 Helm Court Plymouth MI US 48170
30269633993026963399Jenny Jones1N2026-01-0144650 Helm Ct Plymouth MI US 48170

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1826721687114807K253793Materialise TKA Guide SystemJWH2026-01-06
1395191687114807K253793Materialise TKA Guide SystemJWH2026-01-06
1395191881321831K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsPPT2026-01-07
1826721881321831K253308Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides; CMF Plastic ModelsPPT2026-01-07
1395191648626710K251964Mimics Thoracic PlannerLLZ2026-03-12
1826721347529537K251554Materialise TKA Guide SystemJWH2025-07-14
1395191347529537K251554Materialise TKA Guide SystemJWH2025-07-14
1395191292852037K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ2025-02-21
1826721292852037K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ2025-02-21
1826721629518160K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-10-18
1395191629518160K242813Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-10-18
1826721358777051K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-05-22
1395191358777051K241143Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2024-05-22
1395191722410129K233408Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2023-11-09
1395191001029523K233217Mimics Cardiac PlannerLLZ2024-02-12
1395191055088897K231112Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2023-09-12
1395191468238354K230315Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHE2023-03-06
1395191287934806K223427Mimics Enlight CMFLLZ2024-05-31
1826721040878518K221337Materialise TKA Guide SystemJWH2022-07-05
1395191040878518K221337Materialise TKA Guide SystemJWH2022-07-05
1395191207946287K220452Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder PlannerQHE2022-08-17
1395191431307421K212569Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerQHE2022-01-12
1395191776229984K202207Materialise PKA Guide SystemHSX2020-10-02
1395191060352406K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerQHE2020-03-20
1395191609297469K190286Materialise Glenoid Positioning SystemKWS2019-07-08
1395191781074907K173970Materialise PKA Guide SystemHSX2018-07-06
1395191860212778K173445Materialise TKA Guide SystemJWH2018-02-02
1395191276925818K173039TruMatch CMF Titanium 3D Printed ImplantJEY2018-07-10
1826721276925818K173039TruMatch CMF Titanium 3D Printed ImplantJEY2018-07-10
1395191914173473K172650Materialise PKA Guide SystemHSX2017-11-20
1395191388088088K172054Materialise Glenoid Positioning SystemKWS2017-11-03
1395192071211074K170893Materialise Glenoid Positioning SystemKWS2017-06-19
1395191547390648K170272TruMatch CMF Titanium 3D Printed Implant SystemJEY2017-08-08
1826721547390648K170272TruMatch CMF Titanium 3D Printed Implant SystemJEY2017-08-08
1395191383155258K162273Materialise TKA Guide SystemJWH2016-11-07
1395191729657684K153602Materialise Glenoid Positioning SystemKWS2016-04-26
1395191511725520K150928Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA GuidesJWH2015-08-10
1395191559139031K140257SIGNATURE PLANNER, SIGNATURE GUIDESMBH2014-04-02
1395191111522869K140027ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNERJWH2014-05-22
1395191460775197K133162ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLAJWH2014-02-25
1395191043731831K121640ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEMJWH2012-12-05
1395191222780485K113829ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNEJWH2012-04-02
1395191784837376K112389SURGICASE CONNECT, SURGICASE GUIDEPBF2012-07-20
1395191117931285K112301ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNERHSX2012-01-06
1826721665413201K111641SURGICASE ORTHOGNATHIC SOFTWARE WIZARDLLZ2011-09-26
1395191665413201K111641SURGICASE ORTHOGNATHIC SOFTWARE WIZARDLLZ2011-09-26
1395191869621061K111558SURGICASE GUIDEHAW2012-03-27
1826721869621061K111558SURGICASE GUIDEHAW2012-03-27
1395191023234674K111492ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER MODEL 2.5, ZIMMER PATIENT SPECIFIC INSTRUMENTSJWH2011-10-13
1395191903702377K110415SIGNATURE PLANNER / SIGNATURE GUIDESHRY2011-05-16
1826721898256055K103136SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDEJEY2011-03-18
1395191898256055K103136SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDEJEY2011-03-18
1395191954290267K102795SIGNATURE PLANNER; SIGNATURE GUIDESJWH2011-02-02
1395191028644657K093533ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, VERSION 2.0MBH2010-02-17
1395191920212394K091263ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)JWH2009-11-19
1395191180196315K0609503MATICLLZ2006-05-18
1395191008950202
3255151269608375
1826721574967996

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH162026-01-06
QHE102024-10-18
LLZ62026-03-12
JEY62018-07-10
HSX42020-10-02
KWS42019-07-08
PPT22026-01-07
DZJ22025-02-21
MBH22014-04-02
HAW22012-03-27
PBF12012-07-20
HRY12011-05-16