FDA 510(k) Applications Submitted by Medacta International SA

FDA 510(k) Number Submission Date Device Name Applicant
K153273 11/12/2015 MySpine Pedicle Screw Placement Guides - LP Medacta International SA
K210010 01/04/2021 GMK Revision & Hinge Extension - TiNbN Coating Medacta International SA
K200048 01/09/2020 MectaLIF Anterior Simple Medacta International SA
K210062 01/11/2021 Mectaplug PE II Medacta International SA
K170106 01/12/2017 MyKnee PPS-Pin Positioners Medacta International SA
K180089 01/12/2018 Medacta Shoulder System Short Humeral Diaphysis Medacta International SA
K200067 01/13/2020 MectaScope System Medacta International SA
K200075 01/14/2020 3DMetal Diaphyseal Femoral Cones Medacta International SA
K170149 01/17/2017 3DMetal Tibial Cones Medacta International SA
K200122 01/21/2020 MOTO PFJ System Medacta International SA
K200130 01/21/2020 M.U.S.T. MINI Posterior Cervical Screws System Medacta International SA
K210153 01/21/2021 NextAR RSA Platform Medacta International SA
K210207 01/26/2021 Humeral Eccentric Reverse Metaphysis Medacta International SA
K210427 02/11/2021 M.U.S.T. Midline Cortical (MC) Screw System Medacta International SA
K200350 02/12/2020 MyHip Planner & Verifier Medacta International SA
K170452 02/15/2017 Medacta Shoulder System Medacta International SA
K170455 02/15/2017 MectaLIF Anterior Stand Alone Medacta International SA
K210456 02/16/2021 Ligament Staple Medacta International SA
K200391 02/18/2020 MPACT Extension Medacta International SA
K190474 02/27/2019 MectaLock PEEK Suture Anchor Medacta International SA
K200589 03/06/2020 MyPAO Planning Report Medacta International SA
K170690 03/07/2017 M-Vizion Femoral Revision System Medacta International SA
K190631 03/12/2019 M.U.S.T. MINI Posterior Cervical Screws System Medacta International SA
K170845 03/21/2017 MiniMAX Medacta International SA
K190738 03/22/2019 MyShoulder Placement Guides Medacta International SA
K170910 03/28/2017 Medacta Anatomic Shoulder Prosthesis Medacta International SA
K211004 04/02/2021 GMK Spherika Femurs and Fixed Tibial Trays Plus Medacta International SA
K190892 04/05/2019 MectaScrew PEEK Interference Screw Medacta International SA
K171058 04/10/2017 Medacta Shoulder System: Threaded Glenoid Baseplate Medacta International SA
K171170 04/21/2017 M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws Medacta International SA
K191145 04/30/2019 MasterLoc Extension Medacta International SA
K211386 05/05/2021 MySpine WebPlanner & MyBalance Medacta International SA
K171369 05/10/2017 M.U.S.T. MINI Posterior Cervical Screws System Medacta International SA
K211435 05/10/2021 PAO Cortical Screw Medacta International SA
K181254 05/11/2018 Quadra P Medacta International SA
K191300 05/14/2019 MectaLock Ti Suture Anchor Medacta International SA
K171595 05/31/2017 M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System Medacta International SA
K171640 06/02/2017 M-ARS ACL: Anatomic Ribbon Surgery System Medacta International SA
K201471 06/03/2020 M-Vizion Femoral Revision System Extension Medacta International SA
K161635 06/14/2016 AMIStem-H Proximal Coating MEDACTA INTERNATIONAL SA
K171758 06/14/2017 M.U.S.T. Combined Set Screws Medacta International SA
K201673 06/19/2020 SMS Cementless Stem Medacta International SA
K181635 06/21/2018 GMK Sphere CR Tibial Inserts Medacta International SA
K161741 06/24/2016 GMK UNI MEDACTA INTERNATIONAL SA
K191677 06/24/2019 MectaTap TI Suture Anchor Medacta International SA
K181693 06/27/2018 SMS Femoral Stem Medacta International SA
K171966 06/30/2017 Mpact« 3D MetalÖ Implants and Augments 3D MetalÖ Medacta International SA
K191816 07/05/2019 M-Vizion Femoral Revision System Extension Medacta International SA
K181826 07/09/2018 Glenoid Polyaxial Non-locking Screws Medacta International SA
K222169 07/21/2022 FairFix Adjustable Button System Medacta International SA
K162035 07/22/2016 GMK Sphere Medacta International SA
K202022 07/22/2020 GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) Medacta International SA
K181970 07/24/2018 MectaLIF Posterior Extension Medacta International SA
K162061 07/26/2016 M.U.S.T. Pedicle Screw System MEDACTA INTERNATIONAL SA
K162084 07/27/2016 MOTO Partial Knee System Medacta International SA
K172347 08/03/2017 GMK Hinge, GMK Revision Medacta International SA
K202152 08/03/2020 NextAR TKA Platform Medacta International SA
K192126 08/06/2019 AMIStem-P Short Neck Medacta International SA
K172587 08/28/2017 Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers Medacta International SA
K192352 08/29/2019 MiniMAX Medacta International SA
K202568 09/04/2020 Mpact« 3D Metal Implants - DMLS Technology Medacta International SA
K202684 09/15/2020 GMK Total Knee System - TiNbN Coating Medacta International SA
K202730 09/18/2020 Quadra-P Medacta International SA
K192827 10/02/2019 Quadra-P Medacta International SA
K203041 10/06/2020 SMS Cementless Stem Medacta International SA
K182837 10/09/2018 M.U.S.T. Mini Extension Medacta International SA
K173267 10/11/2017 MasterLoc Stem: Lateralized Plus Medacta International SA
K203076 10/13/2020 Mecta-C Stand Alone Extension Medacta International SA
K192906 10/15/2019 Mecta-C Stand Alone Medacta International SA
K203149 10/22/2020 M.U.S.T. MINI Posterior Cervical Screws System Medacta International SA
K183029 11/01/2018 MOTO Partial Knee System Medacta International SA
K193083 11/05/2019 M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System Medacta International SA
K203259 11/05/2020 FairFix Adjustable Button System Medacta International SA
K173472 11/09/2017 MySpine Pedicle Screw Placement Guides û MC and Drill Pilot Instruments Medacta International SA
K203335 11/12/2020 MectaScrew Extension Medacta International SA
K193165 11/15/2019 MectaFix CL Fixation Button with Continuous Loop Medacta International SA
K163311 11/23/2016 GMK Revision Femoral Distal Augmentation Medacta International SA
K203482 11/27/2020 M.U.S.T. Pedicle Screw Extension and Long Tab Implants Medacta International SA
K203485 11/27/2020 SnugFit All-Suture Anchor Medacta International SA
K203493 11/27/2020 MectaLock Extension Medacta International SA
K193365 12/04/2019 M.U.S.T. Pedicle Screw System Medacta International SA
K193433 12/10/2019 AMIStem-C Medacta International SA
K183426 12/11/2018 MectaLIF Anterior Stand Alone Extension Medacta International SA
K173794 12/14/2017 AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared Medacta International SA
K193461 12/16/2019 MectaLock All-Suture Anchors Medacta International SA
K203671 12/16/2020 M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System Medacta International SA
K203673 12/16/2020 MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) Medacta International SA
K173890 12/21/2017 GMK Sphere - Kinematic Alignment Medacta International SA
K183582 12/21/2018 MPACT Extension Medacta International SA
K203755 12/23/2020 Shoulder System - TiNbN Coating Medacta International SA


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