FDA 510(k) Applications Submitted by STRYKER INSTRUMENTS

FDA 510(k) Number Submission Date Device Name Applicant
K250374 02/10/2025 iBur 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, Di Stryker Instruments
K062640 09/06/2006 STRYKER NAVIGATION SYSTEM - CRANIAL MODULE, MODEL 6000-650-000 STRYKER INSTRUMENTS
K050615 03/09/2005 STRYKER NAVIGATION SYSTEM - CT-BASED HIP MODULE, MODEL 6007-621-000 STRYKER INSTRUMENTS
K223294 10/26/2022 SpineJack« Expansion Kit Stryker Instruments
K022162 07/03/2002 STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA STRYKER INSTRUMENTS
K250213 01/24/2025 OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) Stryker Instruments
K961122 03/21/1996 STRYKER KNIFELIGHT STRYKER INSTRUMENTS
K962800 07/18/1996 STRYKER UNIVERSAL DRILL ATTACHMENTS & ACCESSORIES STRYKER INSTRUMENTS
K043442 12/14/2004 STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE STRYKER INSTRUMENTS
K040300 02/09/2004 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) STRYKER INSTRUMENTS
K040369 02/13/2004 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM STRYKER INSTRUMENTS
K050753 03/23/2005 STRYKER DISCMONITOR STRYKER INSTRUMENTS
K061835 06/29/2006 STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLE STRYKER INSTRUMENTS
K032117 07/09/2003 STRYKER TOTAL PERFORMANCE (TPS) SYSTEM STRYKER INSTRUMENTS
K032303 07/25/2003 STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM STRYKER INSTRUMENTS
K061660 06/13/2006 STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE STRYKER INSTRUMENTS
K043466 12/15/2004 PAINPUMP2 STRYKER INSTRUMENTS
K241272 05/06/2024 Stryker Steri-Shield 8 Surgical Hoods and Togas Stryker Instruments
K250327 02/05/2025 OptaBlate Radiofrequency (RF) Generator System Stryker Instruments
K240526 02/23/2024 POWEReam Xia/Serrato Stryker Instruments
K022365 07/22/2002 STRYKER NAVIGATION SYSTEM - HIP MODULE STRYKER INSTRUMENTS
K993061 09/13/1999 STRYKER LEIBINGER RESORBABLE FIXATION SYSTEM STRYKER INSTRUMENTS
K993990 11/24/1999 LEIBINGER QUIK DISK TITANIUM CLAMP SYSTEM STRYKER INSTRUMENTS
K243958 12/23/2024 Consolidated Operating Room Equipment (CORE) 2 Console Stryker Instruments
K243930 12/20/2024 Sonopet iQ Ultrasonic Aspirator System (5500-050-000) Stryker Instruments
K233300 09/29/2023 POWEReam 1/4 Drive Stryker Instruments
K242834 09/19/2024 System 9 Sterile Battery Container Stryker Instruments
K972367 06/25/1997 STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT STRYKER INSTRUMENTS
K242266 08/01/2024 PhotonBlade 3; PhotonBlade 3 Smoke Evacuation Stryker Instruments
K050535 03/02/2005 STRYKER MMF SCREW STRYKER INSTRUMENTS
K030661 03/03/2003 STRYKER PAINPUMP2 STRYKER INSTRUMENTS
K030885 03/21/2003 MODIFICATION TO STRYKER PAINPUMP2 STRYKER INSTRUMENTS
K031249 04/18/2003 MODIFICATION TO STRYKER PAINPUMP STRYKER INSTRUMENTS
K981717 05/15/1998 STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR STRYKER INSTRUMENTS
K991696 05/18/1999 STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM STRYKER INSTRUMENTS
K991703 05/19/1999 STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM STRYKER INSTRUMENTS
K032406 08/04/2003 STRYKER RF ELECTRODES AND CANNULAE STRYKER INSTRUMENTS
K003111 10/04/2000 STRYKER NAVIGATION SYSTEM-SPINE & FLUOROSCOPY MODULES STRYKER INSTRUMENTS
K003543 11/17/2000 STRYKER PAINPUMP PCA STRYKER INSTRUMENTS
K004027 12/27/2000 STRYKER REMOTE SURGICAL PLANNING SYSTEM STRYKER INSTRUMENTS
K232250 07/28/2023 SurgiCount+ System Stryker Instruments
K063005 10/02/2006 STRYKER T6 HOODS AND TOGAS STRYKER INSTRUMENTS
K010969 04/02/2001 NEURO N100 RADIOFREQUENCY GENERATOR AND ACCESSORY CABLES STRYKER INSTRUMENTS
K011381 05/07/2001 HUMMER IV MICRODEBRIDER SYSTEM STRYKER INSTRUMENTS
K032473 08/12/2003 DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBE STRYKER INSTRUMENTS
K002619 08/23/2000 NEWGEN SYSTEM STRYKER INSTRUMENTS
K003486 11/13/2000 STEREOTACTIC FRAME BASED SYSTEM STRYKER INSTRUMENTS
K003660 11/28/2000 LEIBINGER NEURO CLIP SYSTEM STRYKER INSTRUMENTS
K014263 12/27/2001 NEWGEN/UNIVERSAL MANDIBULAR SYSTEM STRYKER INSTRUMENTS
K211238 04/26/2021 SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement Stryker Instruments
K172367 08/04/2017 Stryker Integrated Bipolar Cord and Tubing Sets Stryker Instruments
K994053 11/30/1999 STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE STRYKER INSTRUMENTS
K012991 09/06/2001 NEPTUNE WASTE MANAGEMENT STSTEM STRYKER INSTRUMENTS
K993148 09/21/1999 STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA STRYKER INSTRUMENTS
K972069 06/03/1997 STRYKER INTERPULSE HANDPIECE SET, SPLASH SHIELDS, IRRIGATION AND SUCTION TIPS, RECHARGEABLE BATTERY PACK STRYKER INSTRUMENTS
K970714 02/27/1997 STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) STRYKER INSTRUMENTS
K954483 09/27/1995 STRYKER SAGITTAL SAW ATTACHMENT STRYKER INSTRUMENTS
K222552 08/23/2022 120V 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) Stryker Instruments
K061725 06/19/2006 STRYKER ARIA PNEUMATIC SYSTEM STRYKER INSTRUMENTS
K030378 02/05/2003 STRYKER LEIBINGER CRANIAL FIXATION SYSTEM STRYKER INSTRUMENTS
K021440 05/06/2002 BONESOURCE HAC STRYKER INSTRUMENTS
K031659 05/28/2003 UNIVERSAL NEURO SYSTEM STRYKER INSTRUMENTS
K022185 07/03/2002 UNIVERSAL CMF SYSTEM STRYKER INSTRUMENTS
K032366 08/01/2003 BONESOURCE HAC FAST SETTING CEMENT STRYKER INSTRUMENTS
K043334 12/03/2004 BONE SOURCE HAC RAPID SETTING CEMENT STRYKER INSTRUMENTS


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