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Medacta International S.A. FDA Approvals
0 new drug approvals and 79 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| M-Vizion Femoral Revision System Extension510(k)Sep 17, 2026Orthopedic |
| Mpact 3D Metal Foam510(k)Aug 28, 2026Orthopedic |
| MectaLIF 3D Metal Anterior510(k)May 5, 2026Orthopedic |
| M.U.S.T. Pedicle Screw System - Extension510(k)Apr 28, 2026Orthopedic |
| GMK 3D Metal Tibial Tray Extension510(k)Feb 26, 2026Orthopedic |
| MSS - Monobloc stem510(k)Feb 3, 2026Orthopedic |
| Mpact 3D Metal Implants Extension DMLS Technology510(k)Jan 28, 2026Orthopedic |
| NextAR Hip Platform510(k)Jan 9, 2026Neurology |
| MyPAO SA guides510(k)Nov 19, 2025Orthopedic |
| MSS - Humeral reverse liners extension510(k)Oct 31, 2025Orthopedic |
| Coated hip implants510(k)Sep 19, 2025Orthopedic |
| PowerKnot High Strength Sutures510(k)Sep 12, 2025General, Plastic Surgery |
| NextAR(TM) Shoulder Platform510(k)Sep 4, 2025Neurology |
| Mpact Constrained Liner510(k)Jul 31, 2025Orthopedic |
| NextAR(TM) Spine510(k)Jul 31, 2025Neurology |
| MOTO Partial Knee System Extension510(k)Jul 24, 2025Orthopedic |
| MectaLIF 3D Metal510(k)Jul 17, 2025Orthopedic |
| SnugFit ASA Extension510(k)Jul 1, 2025Orthopedic |
| Mfinity Femoral System510(k)Jun 13, 2025Orthopedic |
| Mpact 3D Metal Augments II510(k)Apr 23, 2025Orthopedic |
| MySpine WebPlanner510(k)Apr 23, 2025Radiology |
| Versacem Acetabular Shell and Double Mobility HC Liners510(k)Mar 6, 2025Orthopedic |
| MyShoulder Planner (5.3SSWPL)510(k)Jan 30, 2025Orthopedic |
| Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System510(k)Jun 12, 2024Orthopedic |
| Mbrace Cable510(k)May 3, 2024Orthopedic |
| NextAR Spine Platform510(k)Apr 24, 2024Neurology |
| M.U.S.T. Pedicle Screw System - Extension510(k)Feb 13, 2024Orthopedic |
| MySpine Cervical Guides510(k)Dec 7, 2023Orthopedic |
| Glenoid Reconstruction System Full Wedge Baseplate510(k)Nov 9, 2023Orthopedic |
| NextAR TSA Platform510(k)Oct 29, 2023Neurology |
| MectaLIF Anterior Lag Extension510(k)Oct 18, 2023Orthopedic |
| Mpact Extension510(k)Sep 20, 2023Orthopedic |
| MySpine Unilateral Guides510(k)Jul 21, 2023Orthopedic |
| NextAR Spine Platform510(k)Jul 21, 2023Neurology |
| MyKnee UNI-ST510(k)Jun 9, 2023Orthopedic |
| MyPAO Guides510(k)May 30, 2023Orthopedic |
| SnugFit All-Suture Anchor extension510(k)Apr 17, 2023Orthopedic |
| MectaLock TI Triple Loaded Suture Anchor510(k)Feb 24, 2023Orthopedic |
| Advanced MyHip Planner510(k)Jan 20, 2023Radiology |
| GMK Sphere & GMK SpheriKA Cementless510(k)Jan 20, 2023Orthopedic |
| FairFix QT Adjustable Button510(k)Jan 17, 2023Orthopedic |
| Glenoid Reconstruction System510(k)Nov 23, 2022Orthopedic |
| MectaLIF Anterior Extension510(k)Oct 24, 2022Orthopedic |
| GMK 3D Metal Tibial Tray510(k)Aug 23, 2022Orthopedic |
| FairFix Adjustable Button System510(k)Aug 16, 2022Orthopedic |
| DM Converter - TiN coated510(k)Jul 22, 2022Orthopedic |
| FairFix AM Adjustable Button FairFix PSP Adjustable Button510(k)Jun 8, 2022Orthopedic |
| M-Vizion Monobloc510(k)May 24, 2022Orthopedic |
| MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides510(k)May 24, 2022Orthopedic |
| MyKnee R Pin Positioners510(k)May 4, 2022Orthopedic |
| M.U.S.T. MINI Posterior Cervical Screws System Extension510(k)Apr 26, 2022Orthopedic |
| Amis K Long510(k)Apr 12, 2022Orthopedic |
| NextAR TKA Platform My Knee PPS510(k)Mar 10, 2022Neurology |
| MectaScrew Extension510(k)Feb 3, 2022Orthopedic |
| Mpact® 3D Metal Implants - DMLS Technology510(k)Dec 20, 2021Orthopedic |
| MOTOTM Partial Knee & MOTO PFJ Systems Extension510(k)Nov 16, 2021Orthopedic |
| NextAR Spine Platform510(k)Nov 5, 2021Neurology |
| MectaLIF Extension510(k)Oct 29, 2021Orthopedic |
| Mpres Neck Preserving Stem510(k)Sep 22, 2021Orthopedic |
| PAO Cortical Screw510(k)Aug 6, 2021Orthopedic |
| GMK Sphere Revision510(k)Jul 29, 2021Orthopedic |
| MySpine WebPlanner & MyBalance510(k)Jul 23, 2021Radiology |
| GMK Spherika Femurs and Fixed Tibial Trays Plus510(k)May 13, 2021Orthopedic |
| NextAR RSA Platform510(k)May 12, 2021Neurology |
| MPACT Extension510(k)Apr 28, 2021Orthopedic |
| M.U.S.T. Midline Cortical (MC) Screw System510(k)Apr 20, 2021Orthopedic |
| Ligament Staple510(k)Apr 12, 2021Orthopedic |
| Mectaplug PE II510(k)Apr 8, 2021General, Plastic Surgery |
| MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides)510(k)Apr 6, 2021Orthopedic |
| Humeral Eccentric Reverse Metaphysis510(k)Mar 26, 2021Orthopedic |
| FairFix Adjustable Button System510(k)Mar 26, 2021Orthopedic |
| GMK Revision & Hinge Extension - TiNbN Coating510(k)Mar 2, 2021Orthopedic |
| Shoulder System - TiNbN Coating510(k)Mar 2, 2021Orthopedic |
| MectaLock Extension510(k)Feb 22, 2021Orthopedic |
| MyPAO Planning Report510(k)Feb 19, 2021Radiology |
| M.U.S.T. Pedicle Screw Extension and Long Tab Implants510(k)Jan 26, 2021Orthopedic |
| SnugFit All-Suture Anchor510(k)Jan 19, 2021Orthopedic |
| M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System510(k)Jan 13, 2021Orthopedic |
| M-Vizion Femoral Revision System Extension510(k)Jan 11, 2021Orthopedic |