FDA.report

Kim Wiersema

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
80101773002821504Kim Wiersema1N2026-01-011941 Stryker Way Portage MI US 49002
30403356713040335671Kim Wiersema1N2026-01-011941 Stryker Way Portage MI US 49002

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
37791506767828P980052TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESISLZD1999-07-02
37791679991978P130014ADHERUS AUTOSPRAY DURAL SEALANTNQR2015-03-30
37791621362773K993583ZURICH TITANIUM OSSICULAR REPLACEMENT SYSTEMETA1999-11-10
37791600100300K993239STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXXHAW2000-01-18
37791214763954K993061STRYKER LEIBINGER RESORBABLE FIXATION SYSTEMMAI1999-11-19
37791269529435K991398BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KITGXP1999-09-22
37792053491605K983885BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATESJEY1999-01-29
37791838756244K983528MICRO DYNAMIC MESHJEY1998-12-23
37791723306195K982040MEDPOR SURGICAL GRANULE IMPLANTSGXP1998-09-08
37791606134061K981717STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTORFTD1998-06-30
37791717850078K981374POREX NOSTRIL RETAINERSLYA1998-07-02
37791479061609K980364HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERSHWC1998-04-29
37791905729664K973982ORBITAL RECONSTRUCTION PLATESHRS1998-01-12
37792009271073K973484CHIN DISTRACTORJEY1997-12-02
37791901675749K972166GUERRERO - BELL DISTRACTORJEY1997-08-11
37791797559131K972154COHEN DISTRACTORJEY1997-08-11
37792039652749K972034MEDPOR OCULAR CONFORMERHQN1998-01-20
37791902278103K971583MEDPOR OCULAR SCREW AND ACCEOSSORIESMQU1997-06-30
37791616420426K970912LEIBINGER SELF-DRILLING SCREWHWC1997-10-01
37791927822292K970911LEE PLATEJEY1997-04-11
37791311678417K970400BONE SOURCE HYDROXYAPATITELZK1997-05-02
37791227360892K964649VAZQUEZ DINER INTRAORAL DISTRACTION DEVICEJEY1997-01-24
37791418819235K963741LEIBINGER LUHR SMALL CRANIOMAXILLOFACIAL BONE SCREWSHRS1997-02-06
37791286725205K963740LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWSJEY1996-10-28
37791876388354K963739LEIBINGER - LUHR SMALL ORTHOPEDIC BONE SCREWSHWC1997-01-22
37792057876219K963502CSCO FOREHEAD FIXATION SYSTEMMBI1997-10-28
37791417180678K963030LEIBINGER IMF SCREWDZE1997-04-11
37791115547412K961719EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESESHRS1997-07-17
37791456211386K961498RESCH ARTHROSCOPIC AND PERCUTANEOUS SCREW FIXATION SYSTEM (A.S.F.)HRS1997-02-06
37791185420643K961485FOREFOOT RECONSTRUCTION SYSTEMHRS1996-06-01
37791828413211K960859MEDPOR OCULAR PEG SYSTEM AND ACCESSORIESHPZ1996-05-29
37791398234184K960297MANDIBULAR BONE DISTRACTOR IIMQN1996-08-06
37791819042973K954939MEDPOR OCULAR SCREW & ACCESSORIESHPZ1996-01-25
37791876234339K952677MEDPOR BARRIER SURGICAL IMPLANT BIOMATERIALFWP1995-08-21
37791815528808K951415LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREWHRS1995-06-22
37791793871320K950595LUHR MANDIBULAR/SMALL FIXATION IMPLANTSJEY1995-07-12
37791056681805K943275MEDPOR SURGICAL IMPLANT MATERIALHPZ1994-09-02
37791169061409K935448LUHR MINI BONE SCREW AND Z PLATEHRS1994-02-23
37791896985268K923861LUHR PAN FIXATION SYSTEMHRS1993-03-04
37792002745392K922489MEDPOR SURG IMPLANT MATERIAL:PREFOR CRAN/FAC IMPLAFWP1992-09-02
37791936067221K913355LUHR PAN FIXATION SYSTEMHRS1991-12-02
37791588612069K901940LUHR MICRO MESHJEY1990-09-06
37792005392148K896450NEURO N 50 LESION GENERATORGXD1991-03-19
37791559995208K882454LUHR MICRO SYSTEMHRS1988-08-19
37791949588963K874911MCCAIN INSTRUMENT TMJ/SM. JOINT ARTHROSCOPIC SURGHRX1988-02-24
37791917131137K862534PAULUS TITANIUM MINI BONE PLATES & BONE SCREWSJEY1986-08-07
37791981651140K862533MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATEJEY1986-08-01
37791760259643K862532DUMBACH TITANIUM MESH IMPLANT SYSTEMJEY1986-09-05
37791213932903K862482STEINHAUSER TITANIUM MINI BONE PLATES & SCREWSJEY1986-07-25
37791513903964K854886WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWSJEY1986-01-21
37791628971491K833586TLS BULB DRAINAGE SYSTEMGCY1984-01-30
37791992746455K832283MEDPAR SURGICAL IMPLANTSFWP1984-05-10
37791394317275K831372TLS SURGICAL MARKERFZZ1983-06-24
37791979811122K800581TLS TM SURGICAL DRAINAGE SYSTEMGCY1980-04-04
37791500224233K761228LUHR MANDIBULAR COMPRESSION-SCREW SYSTEMDZL1976-12-15
37791427740025K254233MEDPOR Customized Implant KitFWP2026-03-12
37791526689363K253623Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air MotorOLO2026-02-19
37791209546035K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting AccessoriesOLO2026-02-06
37791971236275K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip PointerOLO2025-09-25
3420471583459883K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEI2025-09-09
3420471946575592K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond RHBE2025-03-11
37791833683444K243491SternalPlate ExpansionHRS2024-12-11
37791936087384K241517Q Guidance System; Mako Spine System;OLO2024-08-27
37792057972708K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting AccessoriesOLO2024-07-25
3420472057972708K241171Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting AccessoriesOLO2024-07-25
37791128574889K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary HandpieceOLO2024-06-06
37791784089507K240651MRI UniversalJEY2024-07-12
37791614764511K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance SystemOLO2024-03-14
37791917222055K232350Stryker Facial iD SystemJEY2024-01-13
37792062695319K231599Stryker MP, Mandible, HMMF and MMF AXS ScrewsDZL2023-08-24
37792073737728K231208Stryker Resorbable Fixation SystemHBW2023-08-14
37791937233404K230733Stryker Resorbable Fixation SystemJEY2023-08-05
3420471855850085K223770Sonopet 1Q 3 7cm 1Q LargeLFL2023-02-16
37791312287647K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance SystemOLO2023-02-13
37791857694011K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateJEY2022-12-09
37791760048068K221855Universal CMF SystemJEY2022-11-09
37791318674077K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitPGW2022-07-12
37791997889949K220593Spine Guidance Software, Stryker Q Guidance SystemOLO2022-05-27
3420471924183303K213824Sonopet iQ Ultrasonic Aspirator SystemLFL2022-02-03
37791480204918K213777Stryker Resorbable Fixation SystemJEY2022-02-04
37791143870078K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting SystemHAW2023-02-16
3420471193225890K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone CementNDN2021-06-25
3420471870345704K210377Stryker iBur hubs and cutting accessoriesHBE2021-06-30
37791642955328K203228DART-FIRE EDGE Cannulated Screw SystemHWC2021-05-11
37792026663809K203055Stryker PEEK Customized Cranial Implant KitGWO2021-02-09
37791832224252K202609Instrument Clamps ElectromagneticPGW2020-10-09
37791475112238K193143Stryker Facial iD Plating SystemJEY2020-03-26
37791363031317K193136Stryker Customized Mandible Recon Plate KitJEY2020-03-26
3420471701289079K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemPML2020-03-31
37791806265772K191916Stryker CMF MEDPOR Priority Customized Implant KitFWP2019-08-15
3420471316128428K191583PhotonBlade with Smoke EvacuationGEI2020-03-06
37791058803576K190696Stryker Surgeon iD Mandible Recon PlateJEY2019-06-28
37791361144744K190286Materialise Glenoid Positioning SystemKWS2019-07-08
37792017433240K190229Stryker PEEK Customized Cranial Implant KitGWO2019-07-11
37791524071038K183196Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask TrackerOLO2019-02-14
37791725941173K183172Stryker SternalPlate SystemHRS2019-03-05
37791109305140K182425Universal Mesh - SterileGWO2018-11-06
3420471139135309K182354SafeAir Telescopic Smoke PencilGEI2018-12-14
37791701054073K182305Stryker Facial iD Plating SystemJEY2019-01-07
37791807062077K181504Stryker Pediatric Mandibular Distractor 2MQN2018-09-11
37791273543677K173615Stryker Universal Select Sterilization Tray SystemKCT2018-04-18
37791837444094K172572Stryker Upper-Face AXS screws and Mid-Face AXS screwsJEY2017-10-31
37791165214150K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato TapOLO2017-10-18
37791021703777K171661Scopis Extended Instrument Set EMPGW2017-09-27
37791377806351K171364MP LeFort I PlatesJEY2017-07-24
37791212404559K171152Stryker Universal Neuro III System AXS ScrewHBW2017-05-19
37791169158207K170773Stryker Universal MeshJEY2017-11-08
37792012338810K170725Stryker Universal MeshGWO2017-11-13
37791301938601K162937Stryker OrthoMap Versatile Hip SystemOLO2017-02-23
37791432931699K162929Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask TrackerHAW2017-02-22
37791495104426K162341Stryker OrthoMap Precision Knee systemOLO2016-10-12
3420471940351877K162053PhotonBladeGEI2016-09-15
37792045980709K161821Stryker Universal MeshGWO2016-12-08
3420471663537658K161514Precision Thin Reciprocating Blade, 0.010in.EQJ2017-01-17
37791701674757K161491Scopis Hybrid Navigation System EMPGW2017-02-09
3420471196466712K160693Neptune E-SEP Smoke Evacuation PencilGEI2016-04-13
3420471091841389K153679Stryker Neptune E-SEP Smoke Evacuation PencilGEI2016-01-22
37791472633986K153602Materialise Glenoid Positioning SystemKWS2016-04-26
37791863852233K153508Stryker CMF MEDPOR Customized ImplantFWP2016-02-05

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
JEY402024-07-12
OLO212026-02-19
HAW142023-02-16
HRS132024-12-11
GEI112025-09-09
GWO112021-02-09
FWP92026-03-12
HBE72025-03-11
HPZ72007-08-08
PGW52022-07-12
GXP52015-09-02
HBW42023-08-14
HWC42021-05-11
LYA42014-10-23
DZL32023-08-24
LFL32023-02-16
MQN32018-09-11
GXI32013-03-28
NDN22021-06-25
KWS22019-07-08
ETN22016-02-01
ERL22012-05-01
NPK22011-01-07
DZE22004-09-30
GXD21991-03-19
GCY21984-01-30
PML12020-03-31
KCT12018-04-18
EQJ12017-01-17
NQR12015-03-30
NEI12014-04-09
GWF12011-10-06
JOF12009-02-03
HBF12008-12-29
KMW12008-07-29
NHB12007-05-07
HBB12006-10-26
NEA12006-04-19
MQV12005-12-30
KTT12005-08-05