FDA 510(k) Applications Submitted by Medacta International S.A.

FDA 510(k) Number Submission Date Device Name Applicant
K241767 06/20/2024 Versacem Acetabular Shell and Double Mobility HC Liners Medacta International S.A.
K242232 07/30/2024 Mpact 3D Metal Augments II Medacta International S.A.
K220570 02/28/2022 M.U.S.T. MINI Posterior Cervical Screws System Extension Medacta International S.A.
K230544 02/28/2023 SnugFit All-Suture Anchor extension Medacta International S.A.
K220705 03/10/2022 MyKnee R Pin Positioners Medacta International S.A.
K220706 03/10/2022 MyPAO Guides Medacta International S.A.
K220888 03/28/2022 MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides Medacta International S.A.
K251016 04/02/2025 MectaLIF 3D Metal Medacta International S.A.
K231037 04/12/2023 MyKnee UNI-ST Medacta International S.A.
K251166 04/15/2025 Mfinity Femoral System Medacta International S.A.
K241034 04/16/2024 Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System Medacta International S.A.
K241292 05/08/2024 MyShoulder Planner (5.3SSWPL) Medacta International S.A.
K221389 05/13/2022 FairFix AM Adjustable Button FairFix PSP Adjustable Button Medacta International S.A.
K231483 05/23/2023 MySpine Unilateral Guides Medacta International S.A.
K231515 05/25/2023 MySpine Cervical Guides Medacta International S.A.
K221545 05/27/2022 MectaLIF Anterior Extension Medacta International S.A.
K251618 05/27/2025 MOTO Partial Knee System Extension Medacta International S.A.
K211664 06/01/2021 GMK Sphere Revision Medacta International S.A.
K221725 06/14/2022 Advanced MyHip Planner Medacta International S.A.
K211891 06/21/2021 DM Converter - TiN coated Medacta International S.A.
K251933 06/24/2025 SnugFit ASA Extension Medacta International S.A.
K221850 06/27/2022 GMK 3D Metal Tibial Tray Medacta International S.A.
K231911 06/29/2023 Glenoid Reconstruction System û Full Wedge Baseplate Medacta International S.A.
K232123 07/17/2023 MectaLIF Anterior Lag Extension Medacta International S.A.
K212327 07/27/2021 M-Vizion Monobloc Medacta International S.A.
K232280 07/31/2023 NextARÖ TSA Platform Medacta International S.A.
K232733 09/07/2023 Mbrace Cable Medacta International S.A.
K213071 09/23/2021 MOTOTM Partial Knee & MOTO PFJ Systems Extension Medacta International S.A.
K233172 09/28/2023 NextARÖ Spine Platform Medacta International S.A.
K213459 10/27/2021 Glenoid Reconstruction System Medacta International S.A.
K223548 11/25/2022 GMK Sphere & GMK SpheriKA Cementless Medacta International S.A.
K243697 11/29/2024 MySpine WebPlanner Medacta International S.A.
K213751 11/30/2021 NextARÖ TKA Platform My Knee PPS Medacta International S.A.
K223582 12/01/2022 MectaLock TI Triple Loaded Suture Anchor Medacta International S.A.
K223769 12/15/2022 NextARÖ Spine Platform Medacta International S.A.
K223795 12/19/2022 FairFix QT Adjustable Button Medacta International S.A.
K234048 12/21/2023 M.U.S.T. Pedicle Screw System - Extension Medacta International S.A.


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