FDA 510(k) Applications Submitted by STRYKER

FDA 510(k) Number Submission Date Device Name Applicant
K191046 04/19/2019 L10 LED Light Source with AIM, L11 LED Light Source with AIM Stryker
K230416 02/16/2023 Triathlon« Hinge Knee System; Triathlon« Revision Insert X3« Stryker
K173841 12/18/2017 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm Stryker
K200310 02/06/2020 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality Stryker
K230605 03/03/2023 1788 4K Camera System with Advanced Imaging Modality Stryker
K230754 03/17/2023 L12 LED Light Source with AIM Stryker
K181258 05/11/2018 ConnectedOR Hub with Device and Voice Control Stryker
K231854 06/23/2023 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM Stryker
K182160 08/09/2018 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM Stryker
K192292 08/23/2019 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable Stryker
K123486 11/13/2012 TRIATHLON TRITANIUM TIBIAL BASEPLATE Stryker
K171391 05/11/2017 Stryker 90-S Max SERFAS Energy Probe Stryker
K221217 04/27/2022 SPY Laparoscope Stryker
K202659 09/14/2020 Stryker Arthroscope Stryker
K190172 02/01/2019 Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments Stryker
K160955 04/05/2016 Tritanium« PL Cage STRYKER
K162262 08/11/2016 Tritanium« PL Cage STRYKER
K210584 02/26/2021 SDC3 HD Information Management System with Wireless Device Control Capability Stryker
K202592 09/08/2020 Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) Stryker
K200117 01/21/2020 Trevo NXT ProVue Retriever Stryker
K183463 12/14/2018 AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm Stryker
K183464 12/14/2018 AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) Stryker
K220731 03/14/2022 Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem Stryker
K170773 03/14/2017 Stryker Universal Mesh Stryker
K171364 05/09/2017 MP LeFort I Plates Stryker
K181504 06/07/2018 Stryker Pediatric Mandibular Distractor 2 Stryker
K183172 11/16/2018 Stryker SternalPlate System Stryker
K173074 09/29/2017 ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor Stryker
K120352 02/06/2012 STRYKER QUIKFLAP STERILE PROCEDURE PACK Stryker
K121235 04/24/2012 LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM Stryker
K133285 10/25/2013 STRYKER TEMPORARY CONDYLAR PROSTHESIS Stryker
K123786 12/10/2012 STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM Stryker
K173866 12/20/2017 Stryker AIM Light Source and SafeLight cable Stryker
K123452 11/08/2012 TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM Stryker
K210088 01/13/2021 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes Stryker
K211202 04/22/2021 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes Stryker
K191102 04/25/2019 Precision S 4K Sinuscope Stryker
K183470 12/14/2018 Precision Ideal Eyes Arthroscopes Stryker
K170725 03/09/2017 Stryker Universal Mesh Stryker
K171152 04/20/2017 Stryker Universal Neuro III System AXS Screw Stryker
K151387 05/26/2015 Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade STRYKER
K161821 07/01/2016 Stryker Universal Mesh Stryker
K152076 07/27/2015 PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority Stryker
K172572 08/28/2017 Stryker Upper-Face AXS screws and Mid-Face AXS screws Stryker
K153248 11/09/2015 PEEK Customized Cranial Implant STRYKER
K153508 12/07/2015 Stryker CMF MEDPOR Customized Implant Stryker
K142568 09/12/2014 Stryker MEDPOR TITAN 3D Orbital Floor Implant Stryker
K143173 11/04/2014 Stryker CMF MEDPOR Customized Implant Stryker
K133461 11/12/2013 STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM Stryker
K181083 04/24/2018 Stryker All-PEEK Knotless Anchor System Stryker
K171465 05/18/2017 Stryker Self-Punching ICONIX Stryker
K202355 08/19/2020 Stryker Omega PEEK Knotless Anchor System Stryker
K172921 09/25/2017 Stryker Self-Punching ICONIX Stryker
K120509 02/21/2012 STRYKER ALL SUTURE ANCHORS Stryker
K190843 04/01/2019 Synchro2 Support Guidewire Stryker
K121153 04/16/2012 PEEK CUSTOMIZED CRAIAL IMPLANT KIT Stryker
K131775 06/17/2013 UNIVERSAL NEURO 3 SYSTEM Stryker
K113109 10/20/2011 STRYKER RESORBABLE FIXATION SYSTEM Stryker
K133398 11/06/2013 STRYKER PEDIATRIC MANDIBLE DISTRACTOR Stryker
K120816 03/19/2012 INZONE DETACHMENT SYSTEM Stryker
K220895 03/28/2022 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) Stryker
K222130 07/18/2022 1688 4K Camera System with Advanced Imaging Modality Stryker
K212511 08/10/2021 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) Stryker
K201434 06/01/2020 Connected OR Hub with Voice Control, Connected OR Hub with Device Control Stryker
K192172 08/12/2019 Connected OR Hub with Device and Voice Control Stryker
K183381 12/06/2018 Navigation Enabled Instruments STRYKER
K221611 06/03/2022 780 nm L11 LED Light Source with AIM Stryker
K214046 12/27/2021 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable Stryker
K230216 01/26/2023 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) Stryker
K143661 12/23/2014 DirectInject STRYKER
K173476 11/09/2017 Tritanium« TL Curved Posterior Lumbar Cage Stryker
K192122 08/06/2019 Trevo Trak 21 Microcatheter Stryker
K151667 06/19/2015 AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm Stryker
K192207 08/14/2019 Trevo NXT ProVue Retriever Stryker
K190779 03/27/2019 Trevo XP ProVue Retriever Stryker
K122313 08/01/2012 STRYKER UNIVERSAL SMARTLOCK HYBRID MMF SYSTEM Stryker
K132519 08/12/2013 STRYKER CUSTOMIZED MANDIBLE RECON PLATE KIT Stryker
K112557 09/02/2011 STRYKER UNIVERSAL NEURO 3 SYSTEM Stryker
K152304 08/14/2015 Tritanium PL Cage Stryker
K170098 01/11/2017 ICONIX TT All Suture Anchor Stryker
K150584 03/09/2015 Stryker Suture Tape Stryker
K151201 05/05/2015 Stryker ICONIX with Needles Stryker
K162310 08/17/2016 XBraid TT Suture Tape Stryker
K061108 04/20/2006 STRYKER AUTO IRRIGATION SYSTEM Stryker
K112059 07/19/2011 T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP Stryker
K060763 03/21/2006 STRYKER INJECTABLE CEMENT Stryker
K190229 02/05/2019 Stryker PEEK Customized Cranial Implant Kit Stryker
K190696 03/18/2019 Stryker Surgeon iD Mandible Recon Plate Stryker
K182305 08/24/2018 Stryker Facial iD Plating System Stryker
K203055 10/08/2020 Stryker PEEK Customized Cranial Implant Kit Stryker
K193136 11/13/2019 Stryker Customized Mandible Recon Plate Kit Stryker
K193143 11/13/2019 Stryker Facial iD Plating System Stryker


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