Stryker Instruments
Medical device manufacturer in Portage, MI.
74510(k) clearances
0PMA approvals
1recalls
Device types
- HAW Neurological Stereotaxic Instrument 6
- GEI Electrosurgical, Cutting & Coagulation &… 6
- JEY Plate, Bone 5
- FYA Gown, Surgical 5
- FRN Pump, Infusion 4
- GXP Methyl Methacrylate For Cranioplasty 3
- GXI Probe, Radiofrequency Lesion 3
- DZI Drill, Bone, Powered 2
- HBE Drills, Burrs, Trephines & Accessories… 2
- ERL Drill, Surgical, Ent (Electric Or… 2
- OLO Orthopedic Stereotaxic Instrument 2
- GXN Plate, Cranioplasty, Preformed, Non-Alterable 2
- NKB Thoracolumbosacral Pedicle Screw System 2
- NDN Cement, Bone, Vertebroplasty 2
- FTD Lamp, Surgical 2
- CAC Apparatus, Autotransfusion 2
- FQH Lavage, Jet 2
- PBZ Image Processing Device For Estimation Of… 2
- EOB Nasopharyngoscope (Flexible Or Rigid) 1
- GCJ Laparoscope, General & Plastic Surgery 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261544 | Hydro Irrigation SystemEOB · Traditional | 06/17/2026SE |
| K253679 | Hydro Irrigation SystemGWG · Traditional | 05/08/2026SE |
| K252282 | SurgiCount+ SystemPBZ · Traditional | 03/16/2026SE |
| K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip…OLO · Traditional | 09/25/2025SE |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEI · Traditional | 09/09/2025SE |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN…GXI · Traditional | 05/15/2025SE |
| K250327 | OptaBlate Radiofrequency (RF) Generator SystemGEI · Special | 04/15/2025SE |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional | 03/24/2025SE |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 ConsoleOLO · Traditional | 03/21/2025SE |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round…HBE · Special | 03/11/2025SE |
| K242834 | System 9 Sterile Battery ContainerKCT · Traditional | 01/16/2025SE |
| K242266 | PhotonBlade 3; PhotonBlade 3 Smoke EvacuationGEI · Traditional | 10/21/2024SE |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and TogasFYA · Traditional | 10/16/2024SE |
| K240526 | POWEReam Xia/SerratoNKB · Traditional | 04/29/2024SE |
| K232250 | SurgiCount+ SystemPBZ · Traditional | 01/11/2024SE |
| K233300 | POWEReam 1/4 DriveNKB · Traditional | 12/26/2023SE |
| K223294 | SpineJack® Expansion KitNDN · Traditional | 12/20/2022SE |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…JCX · Traditional | 12/09/2022SE |
| K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…NDN · Traditional | 06/25/2021SE |
| K172367 | Stryker Integrated Bipolar Cord and Tubing SetsGEI · Special | 08/22/2017SE |
| K063005 | Stryker T6 Hoods and TogasFYA · Traditional | 03/23/2007SE |
| K062640 | Stryker Navigation System - Cranial Module, Model 6000-650-000HAW · Traditional | 12/14/2006SE |
| K061725 | Stryker Aria Pneumatic SystemHBB · Traditional | 10/26/2006SE |
| K061660 | Stryker RF Parallel Bipolar Adaptor CableGEI · Traditional | 10/10/2006SE |
| K061835 | Stryker Silverglide Bipolar Forceps Reusable Cable; Disposable CableGEI · Traditional | 09/08/2006SE |
| K043442 | Stryker RF Coaxial Bipolar Electrodes & CannulaeGXI · Traditional | 05/31/2005SE |
| K050753 | Stryker DiscmonitorFMF · Traditional | 05/18/2005SE |
| K043466 | PAINPUMP2FRN · Traditional | 05/10/2005SE |
| K050615 | Stryker Navigation System - Ct-Based Hip Module, Model 6007-621-000HAW · Special | 04/21/2005SE |
| K050535 | Stryker MMF ScrewDZL · Traditional | 03/17/2005SE |
| K043334 | Bone Source Hac Rapid Setting CementGXP · Special | 02/09/2005SE |
| K040369 | Stryker Consolidated Operating Room Equipment (Core) SystemDZJ · Traditional | 04/01/2004SE |
| K032406 | Stryker RF Electrodes and CannulaeGXI · Traditional | 04/01/2004SE |
| K040300 | Stryker Consolidated Operating Room Equipment (Core)ERL · Traditional | 03/03/2004SE |
| K032303 | Stryker Consolidated Operating Room Equipment (Core) SystemHBE · Traditional | 01/16/2004SE |
| K032473 | Dekompressor Percutaneous Discectomy ProbeHRX · Traditional | 11/07/2003SE |
| K032366 | Bonesource Hac Fast Setting CementGXP · Traditional | 10/30/2003SE |
| K031659 | Universal Neuro SystemJEY · Traditional | 09/10/2003SE |
| K032117 | Stryker Total Performance (TPS) SystemDZI · Special | 08/08/2003SE |
| K031249 | Modification to Stryker PainpumpFRN · Traditional | 07/21/2003SE |
| K030661 | Stryker PAINPUMP2MEA · Traditional | 05/30/2003SE |
| K030885 | Modification to Stryker PAINPUMP2FRN · Special | 04/18/2003SE |
| K030378 | Stryker Leibinger Cranial Fixation SystemGXN · Traditional | 03/20/2003SE |
| K022365 | Stryker Navigation System - Hip ModuleHAW · Traditional | 01/22/2003SE |
| K022185 | Universal CMF SystemJEY · Traditional | 12/17/2002SE |
| K021440 | Bonesource HacGXP · Traditional | 08/02/2002SE |
| K022162 | Stryker T4 Urethane Hood; Stryker T4 Urethane Zipper Toga; Stryker T4 Urethane Pullover…FYA · Special | 08/01/2002SE |
| K014263 | Newgen/Universal Mandibular SystemJEY · Special | 03/08/2002SE |
| K012991 | Neptune Waste Management StstemFYD · Traditional | 11/29/2001SE |
| K003543 | Stryker Painpump PcaFRN · Traditional | 06/05/2001SE |
| K011381 | Hummer IV Microdebrider SystemERL · Traditional | 05/25/2001SE |
| K003486 | Stereotactic Frame Based SystemHAW · Traditional | 05/17/2001SE |
| K010969 | Neuro N100 Radiofrequency Generator and Accessory CablesGXD · Special | 04/20/2001SE |
| K004027 | Stryker Remote Surgical Planning SystemHAW · Special | 01/24/2001SE |
| K003111 | Stryker Navigation System-Spine & Fluoroscopy ModulesHAW · Traditional | 01/04/2001SE |
| K003660 | Leibinger Neuro Clip SystemJEY · Special | 12/12/2000SE |
| K002619 | Newgen SystemJEY · Traditional | 11/16/2000SE |
| K993990 | Leibinger Quik Disk Titanium Clamp SystemGXN · Traditional | 02/22/2000SE |
| K994053 | Stryker T4 Power Pack, Stryker T4 Eight Station Battery Charger, Stryker T4 Charger ModuleFYA · Special | 12/20/1999SE |
| K993061 | Stryker Leibinger Resorbable Fixation SystemMAI · Traditional | 11/19/1999SE |
| K991696 | Stryker Hermes-Ready Total Performance SystemDZI · Traditional | 10/25/1999SE |
| K993148 | Stryker T4 Hood, Stryker T4 Zippered Toga, Stryker T4 Pullover TogaFYA · Special | 10/15/1999SE |
| K991703 | Stryker Hermes-Ready Total Performance SystemGCJ · Special | 05/27/1999SE |
| K981717 | Stryker Knifelight, Stryker Illuminated RetractorFTD · Traditional | 06/30/1998SE |
| K970714 | Stryker Constavac Blood Conservation System II (Cbcii)CAC · Traditional | 12/16/1997SE |
| K972367 | Stryker System 4000 Heavy Duty Battery Powered EquipmentKIJ · Traditional | 09/04/1997SE |
| K972069 | Stryker Interpulse Handpiece Set, Splash Shields, Irrigation and Suction Tips…FQH · Traditional | 07/29/1997SE |
| K962800 | Stryker Universal Drill Attachments & AccessoriesHWE · Traditional | 09/11/1996SE |
| K961122 | Stryker KnifelightFTD · Traditional | 08/22/1996SE |
| K954483 | Stryker Sagittal Saw AttachmentGFA · Traditional | 01/30/1996SE |
| K952224 | Stryker Constavac Blood Conservation System II (Cbcii)CAC · Traditional | 11/17/1995SE |
| K951666 | Stryker Interpulse Handpiece Set, Irrigation Tips, Splash Shields, Canal Vision Tip…FQH · Traditional | 09/19/1995SE |
| K953071 | Stryker COMMAND2 Office ConsoleJEA · Traditional | 08/08/1995SE |
| K921805 | Stryker Precision Dental Implant SystemDZE · Traditional | 03/10/1994SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1478-2022 Class II | Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy…There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break… | 06/24/2022Open, Classified |