FDA.report

Stryker Instruments

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30159673593015967359Stryker Instruments1Y2026-01-011941 Stryker Way Portage MI US 49002

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2359121198332413K992931NON-STICK BIPOLAR FORCEPSGEI1999-11-17
2359121665168098K981751SINUSCOPE AND ACCESSORIESEOB1998-08-13
2359121579776200K972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTKIJ1997-09-04
2359121277198517K955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEGDY1996-02-22
2359121597699193K951985PRECISION BIPOLAR COAGULATORGEI1995-05-23
2359121997153776K944393STRYKER STERI-SHIELD SURGICAL APPARELFYA1995-08-28
2359121757324633K943569STRYKER TOTAL PERFORMANCE SYSTEMERL1995-01-09
2359121497228030K94354175K STAIGHT DRILLHBE1995-05-18
2359121947854556K943540SURGICAL CUTTING BURSDZJ1994-11-30
2359121035746617K943323STRYKER SURGICAL INSTRUMENTS AND ACCESSORIESHRX1994-11-28
2359121720862681K941605STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSHLXH1994-08-05
2359121613540198K931847BIO-PREP CEMENT RESTRICTORLZN1994-06-28
2359121747540583K912190STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYSTJDZ1991-08-29
2359121963638678K896541MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-IIIGEI1990-01-29
2359121911946742K881913PROTECTO-SHIELDFXX1988-07-08
2359121083817505K253679Hydro Irrigation SystemGWG2026-05-08
2359121526689363K253623Spine 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
2359121209546035K252871Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting AccessoriesOLO2026-02-06
2359121971236275K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip PointerOLO2025-09-25
2359121213123422K251156NPsealOKO2025-05-15
2359121348525000K250708NPsealOKO2025-04-08
2359121583459883K250483PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEI2025-09-09
2359121946575592K250374iBur 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
2359121454492389K250327OptaBlate Radiofrequency (RF) Generator SystemGEI2025-04-15
2359121567374258K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)GXI2025-05-15
2359121309933521K243958Consolidated Operating Room Equipment (CORE) 2 ConsoleOLO2025-03-21
2359121397128925K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL2025-03-24
2359121541918110K242834System 9 Sterile Battery ContainerKCT2025-01-16
2359121077763564K241522NPseal (20 and 25)OKO2024-08-15
2359121936087384K241517Q Guidance System; Mako Spine System;OLO2024-08-27
2359121903432166K241272Stryker Steri-Shield 8 Surgical Hoods and TogasFYA2024-10-16
2359122057972708K241171Spine 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
2359121128574889K240662Spine 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
2359121211090800K240526POWEReam Xia/SerratoNKB2024-04-29
2359121885124893K240244NPseal (Small, Medium, Large)OKO2024-02-29
2359122030005266K233800Vertos mild Device Kit (MDK-0002)HRX2024-05-06
2359121268932732K233300POWEReam 1/4 DriveNKB2023-12-26
2359121795995156K232567Myriad SPECTRA Light SourceQFX2024-03-14
2359121703884539K232250SurgiCount+ SystemPBZ2024-01-11
2359121855850085K223770Sonopet 1Q 3 7cm 1Q LargeLFL2023-02-16
2359121013487395K223294SpineJack® Expansion KitNDN2022-12-20
2359121816915807K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)JCX2022-12-09
2359121934523525K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceGEI2022-09-16
2359121505894358K220027Audion ET dilation systemPNZ2022-04-12
2359121924183303K213824Sonopet iQ Ultrasonic Aspirator SystemLFL2022-02-03
2359121757355349K212971NPsealOKO2022-02-10
2359121594166459K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000ERL2021-06-09
2359121193225890K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone CementNDN2021-06-25
2359121212623064K211130NPsealOKO2021-05-14
2359121870345704K210377Stryker iBur hubs and cutting accessoriesHBE2021-06-30
2359121151928210K200493Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, PulloverFXY2020-03-21
2359121164254773K200305NPsealOKO2020-05-26
2359121797350066K193502TGS Universal Headrest with Mounting ArmPGW2020-02-14
2359121700583036K193118TGS Guidewire and updated Scopis SoftwarePGW2020-02-21
2359121701289079K192818Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal SystemPML2020-03-31
2359121368656052K192661LATERA Absorbable Nasal Implant SystemNHB2019-11-10
2359121740640257K191599NICO Myriad NOVUSGEI2019-09-13
2359121316128428K191583PhotonBlade with Smoke EvacuationGEI2020-03-06
2359121254524702K191049Stryker MIS and Footed AttachmentsHBE2019-06-18
2359121340905541K190356ClariFixGEH2019-02-26
2359121262941126K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE2019-06-14
2359121262941126K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE2019-06-14
2359121394685657K190070Sonopet iQ Ultrasonic Aspirator SystemLFL2019-04-11
2359121139135309K182354SafeAir Telescopic Smoke PencilGEI2018-12-14
2359121544002320K182340NICO MyriadGEI2018-09-20
2359121567233772K182224SafeAir Smoke Evacuator compactFYD2019-02-07
2359121075490130K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRX2018-12-21
2359121688207263K181262SpineJack Expansion KitNDN2018-08-30
2359121252313397K180327Stryker iVAS 13g Bone Biopsy KitKNW2018-02-26
2359122022530595K172558iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy KitKNW2017-10-05
2359121122575109K172433NICO BrainPathGZT2017-09-07
2359121604764313K172367Stryker Integrated Bipolar Cord and Tubing SetsGEI2017-08-22
2359121329263180K172365Panoramic Oxygen Mask (POM)CCK2018-04-19
2359121047482480K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRX2018-01-25
2359121456440521K171840Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERL2017-09-15
2359121453524752K170242MultiGen™ 2 RF Generator SystemGXD2017-05-25
2359121044650247K170003Zip 4 Skin Closure DevicePYO2017-08-18
2359121861662661K163509XprESS ENT Dilation SystemPNZ2017-04-05
2359121003226183K163507Triton Sponge SystemPBZ2017-04-25
2359121619868673K163435Entellus Medical Reinforced Anesthesia NeedleBSP2017-04-05
2359121379241745K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonHRX2016-11-01
2359121940351877K162053PhotonBladeGEI2016-09-15
2359121663537658K161514Precision Thin Reciprocating Blade, 0.010in.EQJ2017-01-17
2359122008017237K161191Latera Absorbable Nasal ImplantNHB2016-06-23
2359121196466712K160693Neptune E-SEP Smoke Evacuation PencilGEI2016-04-13
2359121091841389K153679Stryker Neptune E-SEP Smoke Evacuation PencilGEI2016-01-22
2359121314670529K153407Stryker Neptune 3 Waste Management SystemJCX2016-04-25
2359121677604780K152641Pi Drive Plus Motor, ExtenderERL2015-11-20
2359121067997162K152435PassAssist LED Light FiberLRC2015-11-20
2359121987072691K152434XprESS Multi-Sinus Dilation SystemLRC2015-11-20
2359121666067726K151125AVAflex Vertebral Balloon SystemHRX2015-11-24
2359121889157451K150801Stryker Maestro Air MotorsHBB2015-05-22
2359121397622904K150582Vertaplex® High Viscosity (HV) Radiopaque Bone CementNDN2015-06-12
2359121712707942K150523AVAmax Vertebral BalloonHRX2015-10-29
2359121707280989K143540Stryker MIS Attachments and Cutting AccessoriesHBE2015-05-01
2359121411259336K143399Stryker Footed Attachments and Cutting AccessoriesHBE2015-05-08
2359121779407819K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE2015-04-23
2359121924428706K143145SafeAir Smoke PencilGEI2014-12-04
2359121428674324K142801Triton Canister SystemPBZ2015-03-12
2359121346519799K142538LiNA SafeAir Smoke PencilGEI2014-10-06
2359121719758922K142252XprESS Multi-Sinus Dilation ToolLRC2014-10-17
2359121564125298K141935STRYKER S2 DRILLERL2014-09-26
2359121411244268K141816HEMOPORELYA2014-10-23
2359121297437362K141673IVAS 8 GAUGE BONE BIOPSY KITKNW2014-09-04
2359121679748281K141423NASOPORE-FDLYA2014-08-07
2359121440294765K141095STRYKER STERI-SHIELD FLYTE HYBRID TOGASFYA2014-08-26
2359121076490000K140588FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSFXY2014-06-26
2359121274419742K133563PATHASSIST LIGHT SEEKERLRC2013-12-20
2359121885844819K132671STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEMJCX2013-12-20
2359121064649947K131820AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11GHRX2013-10-04
2359121368432924K130430IVAS 10MM AND 15MM BALLOON CATHETERHRX2013-05-23
2359121989811180K123942STRYKER IVAS BALLOON CATHETERNDN2013-04-03
2359121187776774K123178STRYKER VENOM ELECTRODES AND CANNULAEGXI2013-03-28
2359121639891299K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPSGEI2012-07-10
2359121067286881K120454SAFEAIR SMOKE PENCIL,GEI2012-12-07
2359121569315793K113585NASAL/EPISTAXIS PACKLYA2012-04-25
2359121486084126K112593STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMERL2012-05-01
2359121928325737K110924DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPSGEI2011-12-07
2359121743408831K093062VERTOS MEDICAL MILD DEVICE KITHRX2010-02-04
2359121845029804K082010STRYKER DISPOSABLE CRANIAL PERFORATOR BITHBF2008-12-29

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GEI242025-09-09
HRX112024-05-06
HBE102025-03-11
ERL92021-06-09
NDN82022-12-20
OLO72026-02-19
OKO72025-05-15
LFL62025-03-24
FYA62024-10-16
KNW52018-02-26
PBZ42024-01-11
LRC42015-11-20
LYA42014-10-23
GXI32025-05-15
JCX32022-12-09
NHB32019-11-10
HBB32015-05-22
NKB22024-04-29
PNZ22022-04-12
FXY22020-03-21
PGW22020-02-21
FYD22019-02-07
GXD22017-05-25
LOD22004-05-25
DZJ22004-04-01
GWG12026-05-08
KCT12025-01-16
QFX12024-03-14
PML12020-03-31
GEH12019-02-26
CCK12018-04-19
GZT12017-09-07
PYO12017-08-18
BSP12017-04-05
EQJ12017-01-17
HBF12008-12-29
LWH12006-03-14
FMF12005-05-18
DZI12003-08-08
LYU12001-06-22

PMN

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