FDA 510(k) Applications Submitted by MEDOS International SARL

FDA 510(k) Number Submission Date Device Name Applicant
K211344 05/03/2021 MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems Medos International SARL
K220219 01/26/2022 PERMALOOP Suture, PERMATAPE Suture Medos International SARL
K221364 05/11/2022 Mitek TIGHT-N Anchor Medos International SARL
K180101 01/16/2018 HEALIX ADVANCE KNOTLESS BR Anchor Medos International SARL
K191483 06/04/2019 HEALIX ADVANCE Anchor with DYNA+TAPE Sutures Medos International SARL
K171439 05/16/2017 EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, U Medos International SARL
K101070 04/16/2010 EXPEDIUM SPINE SYSTEM MEDOS INTERNATIONAL SARL
K152670 09/17/2015 DirectLink ICP Module, DirectLink ICP Extension Cable, Patient Monitor Interface Cables Medos International SARL
K200949 04/09/2020 HEALIX ADVANCE Anchor with DYNATAPE Suture Medos International SARL
K191242 05/09/2019 HEALIX ADVANCE SP BIOCOMPOSITE Anchor Medos International SARL
K201883 07/08/2020 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor Medos International SARL
K182941 10/23/2018 HEALIX ADVANCE SP PEEK Anchor Medos International SARL
K203794 12/28/2020 HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture Medos International Sarl
K232492 08/17/2023 2.7 mm GRYPHONÖ Flex Knotless PEEK Anchor; 2.7 mm GRYPHONÖ Flex Knotless Biocomposite Anchor Medos International SARL
K203319 11/12/2020 SYMPHONYÖ OCT System Medos International Sarl
K120517 02/21/2012 DEPUY PULSE CERVICAL CAGE SYSTEM MEDOS INTERNATIONAL SARL
K112724 09/19/2011 DEPUY PULSE ANTERIOR CERICAL PLATE SYSTEM MEDOS INTERNATIONAL SARL
K123167 10/09/2012 DEPUY PULSE ANTERIOR CERVICAL IN-LINE PLATE SYSTEM MEDOS INTERNATIONAL SARL
K113396 11/07/2011 DEPUY PULSE THORACOLUMBAR SCREW SYSTEM MEDOS INTERNATIONAL SARL
K214025 12/22/2021 PROWLER SELECT LP ES Microcatheter; PROWLER XS Microcatheter Medos International Sarl
K161638 06/14/2016 SPEEDTRAP Graft Preparation System MEDOS INTERNATIONAL SARL
K151352 05/20/2015 CONCORDE Bullet Spinal System MEDOS INTERNATIONAL SARL
K162469 09/02/2016 CODMAN VersaTru Standard Disposable Non-Stick Bipolar Forceps, CODMAN VersaTru Slim Disposable Non-Stick Bipolar Forceps Medos International SARL
K112156 07/27/2011 CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM MEDOS INTERNATIONAL SARL
K152152 08/03/2015 Codman Certas Plus Programmable Valve Medos International Sarl
K113526 11/30/2011 CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM MEDOS INTERNATIONAL SARL
K170639 03/02/2017 HEALIX ADVANCE Anchor with PERMATAPE Suture Medos International SARL
K171114 04/14/2017 HEALIX ADVANCE KNOTLESS Anchor Medos International SARL
K160904 04/01/2016 Expedium Spine System, VIPER and VIPER 2 Systems MEDOS INTERNATIONAL SARL
K130877 03/29/2013 EXPEDIUM SPINE SYSTEM MEDOS INTERNATIONAL SARL
K140927 04/11/2014 UNIVERSAL NAVIGATION INSTRUMENTS MEDOS INTERNATIONAL SARL
K132332 07/26/2013 MOUNTAINEER OCT SPINAL SYSTEM MEDOS INTERNATIONAL SARL
K132324 07/26/2013 SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM, UNIPLATE 2 ANTERIOR CERVICAL PLATE SYST MEDOS INTERNATIONAL SARL
K122896 09/21/2012 COUGAR LS 15 LATERAL CAGE SYSTEM MEDOS INTERNATIONAL SARL
K160804 03/23/2016 INTRAFIX(TM) Advance Tibial Fastener System MEDOS INTERNATIONAL SARL
K161001 04/11/2016 MILAGRO ADVANCE PEEK Interference Screw MEDOS INTERNATIONAL SARL
K153667 12/21/2015 TRUESPAN Meniscal Repair System Medos International SARL
K120867 03/22/2012 VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS MEDOS INTERNATIONAL SARL
K190774 03/26/2019 RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant Medos International SARL
K190284 02/11/2019 Bengal Stackable Cage System Medos International SARL
K163106 11/07/2016 CODMAN Integrated Bipolar Cord and Tubing Set Medos International SARL
K220374 02/09/2022 EXPEDIUM VERSE« Fenestrated Screw System (Sterile Fenestrated Screws) Medos International SARL
K231479 05/22/2023 TriALTIS Spine System Medos International SARL
K192804 10/01/2019 CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm Medos International SARL
K143111 10/29/2014 Codman Certas Plus Programmable Valve; Codman Certas Toll Kit MEDOS INTERNATIONAL SARL
K183279 11/23/2018 HEALIX Ti ANCHOR with DYNACORD Medos International SARL
K212756 08/31/2021 Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set MEDOS International SARL
K120966 03/30/2012 DEPUY PULSE LUMBAR CAGE SYSTEM MEDOS INTERNATIONAL SARL
K112907 10/03/2011 CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G MEDOS INTERNATIONAL SARL
K210838 03/22/2021 PROWLER SELECT PLUS; PROWLER EX Medos International SARL
K191212 05/06/2019 CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, Medos International SARL
K192281 08/22/2019 AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoli Medos International SARL
K190895 04/05/2019 MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System Medos International Sarl
K181949 07/20/2018 SYMPHONYÖ OCT System Medos International SARL
K192014 07/29/2019 SYPMHONYÖ OCT System Medos International SARL
K192646 09/24/2019 SYMPHONYÖ OCT System Medos International SARL
K173134 09/29/2017 SENTIO MMG Pedicle Access Needles Medos International SARL
K173787 12/14/2017 X-MESH« Expandable Cage System, OCELOT« Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE« System, CONCORDE« Inline Lumbar Interbody System, CONCORDE« Curve Lumbar Interbody Medos International SARL
K133941 12/23/2013 MITEK ARTHROSCOPES MEDOS INTERNATIONAL SARL
K112345 08/15/2011 DISTAL VOLAR RADIUS PLATING SYSTEMS MEDOS INTERNATIONAL SARL
K171237 04/27/2017 FMS VUE II Fluid Management and Tissue Debridement System Medos International SARL
K181182 05/03/2018 DYNACORD Suture Medos International SARL
K181809 07/06/2018 GRYPHON« Anchors with DYNACORDÖ Suture Medos International SARL
K162247 08/10/2016 PERMATAPE MEDOS INTERNATIONAL SARL
K203186 10/27/2020 DYNATAPE Suture Medos International SARL
K183506 12/18/2018 HEALIX ADVANCE Anchor with DYNACORD Suture Medos International SARL
K173859 12/20/2017 HEALIX ADVANCE Anchor with DYNACORD Suture Medos International SARL
K173095 09/29/2017 VIPER PRIMEÖ Screws, VIPER PRIMEÖ Screws with Fenestrations, EXPEDIUM« Verse Screws with Fenestrations Medos International SARL


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