FDA 510(k) Applications Submitted by KI HYANG KIM

FDA 510(k) Number Submission Date Device Name Applicant
K120840 03/20/2012 LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED CO., LTD
K120879 03/23/2012 LEXUS CERVICAL FIXATION SYSTEM L & K BIOMED CO., LTD
K121096 04/11/2012 VENUS LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM L & K BIOMED CO., LTD
K143271 11/13/2014 CastleLoc-P Anterior Cervical Plate System L&K BIOMED Co., Ltd
K143279 11/14/2014 LnK Anterior Cervical Plate System L&K BIOMED Co., Ltd.
K143363 11/24/2014 VENUS Spinal Fixation System L&K BIOMED Co., Ltd.
K250892 03/25/2025 CastleLoc Pectus Bar System L&K Biomed Co., Ltd.
K251741 06/06/2025 PathLoc Lumbar Interbody Fusion Cage System L&K BIOMED Co., Ltd.
K240201 01/25/2024 PathLoc SI Joint Fusion System L&K Biomed Co., Ltd.
K200789 03/26/2020 LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System L&K BIOMED Co., Ltd.
K200793 03/26/2020 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System L&K BIOMED Co., Ltd.
K200790 03/26/2020 LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System L&K BIOMED Co., Ltd.
K200794 03/26/2020 AccelFix Spinal Fixation System L&K BIOMED Co., Ltd.
K221050 04/11/2022 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System Aegis Spine, Inc.
K221719 06/13/2022 ABTross ALIF Expandable Cage System Aegis Spine, Inc.
K192481 09/10/2019 AccelFix Lumbar Plate System L&K Biomed Co., Ltd.
K242829 09/19/2024 BluEX Lumbar Expandable Cage System L&K BIOMED Co., Ltd.
K243357 10/29/2024 CastleLoc Pectus Bar System L&K BIOMED Co., Ltd.
K223521 11/23/2022 ZESPIN SI Joint Fusion System Aegis Spine, Inc.
K223719 12/12/2022 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System Aegis Spine, Inc.
K060179 01/23/2006 BIO-RAY SDX DIGITAL X-RAY SYSTEM SIGMA BIOMEDICS, INC.
K103600 12/08/2010 PORTABLE X-RAY SYSTEM DIGIMED CORPORATION
K970376 02/03/1997 PTCA GUIDEWIRE LAKE REGION MFG., INC.
K970994 03/19/1997 CORE AND COIL ASSEMBLY GUIDEWIRE LAKE REGION MFG., INC.
K971322 04/10/1997 CORE AND COIL ASSEMBLY GUIDEWIRE LAKE REGION MFG., INC.
K031891 06/13/2003 VIRTUOSAPH TERUMO CARDIOVASCULAR SYSTEMS CORP.
DEN070014 06/20/2007 MANDOMETER III AB MANDO
K083693 12/12/2008 PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
K063698 12/13/2006 CO2 LASER SYSTEM, MODEL C-LAS CLINICON CORP.
K222297 08/01/2022 CentriMag Pre-connected Pack Abbott
K242215 07/29/2024 Neurophet AQUA (V3.1) Neurophet, Inc.
K181852 07/11/2018 Percuvance Percutaneous Surgical System Teleflex Medical, Inc.
K142492 09/04/2014 GM60A-32S, GM60A-40S SAMSUNG ELECTRONICS CO., LTD.
K143029 10/21/2014 Digital Diagnostic X-ray System (GC80) SAMSUNG ELECTRONICS CO., LTD.
K150550 03/03/2015 SilverCoat Silicone Foley Catheter COVALON TECHNOLOGIES, INC.
K112549 09/01/2011 IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER COVALON TECHNOLOGIES, INC.
K163556 12/19/2016 MediClear PreOp COVALON TECHNOLOGIES, INC.
K243470 11/08/2024 Fix2Lock (PEEK Self Punching) Osteonic Co., Ltd.
K243467 11/08/2024 Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) OSTEONIC Co., Ltd.
K113323 11/10/2011 ARTUS INFL A/B RG RT-PCR KIT QIAGEN, GMBH
K241480 05/24/2024 JBS-LVO JLK, Inc.
K161829 07/05/2016 Huvitz Imaging System HUVITZ CO., LTD.
K220024 01/05/2022 ChoiceSpine Navigation System ChoiceSpine, LLC
K140142 01/22/2014 CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON) CHOICE SPINE, LP
K190227 02/05/2019 BoomerangÖ Anterior Cervical Plate System ChoiceSpine, LP
K180519 02/27/2018 HARRIER-SAÖ Lumbar Interbody System Choice Spine, LP
K170821 03/20/2017 ChoiceSpineÖ Proliant« Posterior Pedicle Screw and Hook Fixation System Choice Spine, LP
K160775 03/21/2016 ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems CHOICE SPINE LP
K170942 03/30/2017 The ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems Choice Spine, LP
K170953 03/31/2017 Tomcat Cervical Spinal System Choice Spine, LP
K220953 04/01/2022 ChoiceSpine TigerSharkÖ M, Modular Interbody System ChoiceSpine, LLC
K211449 05/10/2021 TritonÖ Sacroiliac Joint Fixation System ChoiceSpine, LLC
K171456 05/17/2017 ThunderboltÖ Minimally Invasive and LancerÖ Open Pedicle Screw Systems Choice Spine
K171489 05/22/2017 Acapella Cervical Spacer System Choice Spine, LP.
K191367 05/22/2019 Harrier-SA Lumbar Interbody System ChoiceSpine LLC
K171686 06/07/2017 Choice Spine HawkeyeÖ Vertebral Body Replacement (VBR) System Choice Spine
K201643 06/17/2020 ChoiceSpine Tiger Shark Cervical Spacer System ChoiceSpine, LLC
K191621 06/18/2019 ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octan ChoiceSpine, LLC
K121850 06/25/2012 Typhoon(TM) Facet Screw Fixation System CHOICE SPINE, LP
K132049 07/02/2013 THUNDERBOLT AND LANCER PEDICLE SCREW SYSTEMS CHOICE SPINE
K162103 07/29/2016 Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine Interbody Fusion System (HarrierÖ), Choice Spine Vertebral Body Replacement System (HawkeyeÖ) CHOICE SPINE, LP
K152515 09/02/2015 TOMCAT Cervical Spinal System CHOICE SPINE, LP
K172816 09/18/2017 TiGer SharkÖ System Choice Spine, LP.
K182721 09/28/2018 Choice Spine Navigation System Choice Spine, LP.
K173215 10/02/2017 Choice Spine LaminoplastyÖ Fixation System Choice Spine, LP
K133214 10/18/2013 BLACKBIRD SPINAL SYSTEM CHOICE SPINE, LP
K153107 10/27/2015 Choice Spine Lumbar Spacer System (SabreÖ, SharkÖ, HornetÖ, HarpoonÖ), Choice Spine VEOÖ Lateral Access & Interbody Fusion System, Choice Spine Interbody Fusion System CHOICE SPINE, LP
K203311 11/10/2020 ChoiceSpine Blackhawk Ti Cervical Spacer System ChoiceSpine, LLC
K183214 11/19/2018 Raven Lumbar Plate System Choice Spine, LP
K183397 12/07/2018 ChoiceSpine Stealth Cervical Spacer System ChoiceSpine, LP
K203561 12/07/2020 ChoiceSpine Navigation System ChoiceSpine, LLC
K183588 12/21/2018 Choice Spine Hawkeye Vertebral Body Replacement (VBR) System Choice Spine
K223869 12/23/2022 ChoiceSpine Blackhawk Ti Cervical Spacer System ChoiceSpine, LLC
K120274 01/30/2012 DELTAMAXX 18 MICROCOIL SYSTEM CODMAN AND SHURTLEFF, INC.
K120686 03/06/2012 ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM Codman & Shurtleff, Inc.
K040725 03/22/2004 BD FACSCANTO SYSTEM BECTON DICKINSON IMMUNOCYTOMETRY SYSTEMS
K130981 04/09/2013 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM CORDIS CORP.
K041074 04/26/2004 BD FACSCANTO WITH BD FACSANTO SOFTWARE BD Biosciences
K073231 11/15/2007 ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC.
K133843 12/18/2013 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER CORDIS CORPORATION
K200530 03/02/2020 AMICUS Separator System Fresenius Kabi AG
K180615 03/08/2018 AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter Fresenius Kabi USA LLC
K141019 04/21/2014 AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHED FENWAL, INC.
K111702 06/17/2011 AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE FENWAL, INC.
K162462 09/02/2016 AMICUS Separator System, AMICUS Separator System; Refurbished FRESENIUS KABI USA LLC
K240025 01/03/2024 Clearblue« Early Detection Pregnancy Test SPD Swiss Precision Diagnostics GmbH
K962775 07/16/1996 SUNGLASSES (NON-PRESCRIPTION) CANADD TRADING CO.
K231225 04/28/2023 EConsole1 DRTECH Corporation
K233530 11/02/2023 EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi DRTECH Corporation
K190471 02/26/2019 4CIS« Chiron Spinal Fixation System Solco Biomedical Co., Ltd.
K162402 08/26/2016 4CIS« Marlin ACIF Cage System SOLCO BIOMEDICAL CO., LTD.
K211114 04/14/2021 Will3D HDX WILL CORP.
K231213 04/28/2023 HKT Anatomical Locking Trauma System Hankil Tech Medical Co., Ltd
K181142 05/01/2018 Absoanchor Microimplant Dentos Inc
K150478 02/24/2015 A35 Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD.
K151808 07/02/2015 3D/5D Viewer SAMSUNG MEDISON CO., LTD
K232665 08/31/2023 GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air for Women (CH14) ConvaTec
K233921 12/13/2023 Luvis Chair (LC700C) DENTIS CO., LTD.
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K040929 04/09/2004 TRIGEN ADOLESCENT TAN SMITH & NEPHEW, INC.
K041106 04/28/2004 REVISION KNEE SYSTEM SMITH & NEPHEW, INC.
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