Medical Device Manufacturer · CH , Castel San Pietro

Medacta International S.A. - FDA 510(k) Cleared Devices

167 submissions · 167 cleared · Since 2008

Recent clearances: M-Vizion Femoral Revision System Extension, Mpact 3D Metal Foam, MectaLIF 3D Metal Anterior

View 167 510(k) Devices ↓ Official Website

167

Total

167

Cleared

Denied

Medacta International S.A. has 167 FDA 510(k) cleared orthopedic devices. Based in Castel San Pietro, CH.

Latest FDA clearance: Sep 2026. Active since 2008.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Medacta USA, Mapi USA, Inc. and Underwriters Laboratories, Inc..

Medacta International S.A. is one of 141 FDA 510(k) medical device manufacturers from Switzerland in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Medacta International S.A.

167 devices

1-12 of 167

1 2 3 4

Cleared Sep 17, 2026

M-Vizion Femoral Revision System Extension

MectaLIF 3D Metal Anterior

K254202 · OVD

Orthopedic · 127d

Cleared Apr 28, 2026

M.U.S.T. Pedicle Screw System - Extension

K253940 · NKB

Orthopedic · 140d

Cleared Feb 26, 2026

GMK 3D Metal Tibial Tray Extension

Mpact 3D Metal Implants Extension – DMLS Technology

MSS - Humeral reverse liners extension

PowerKnot High Strength Sutures

K252225 · GAT

General & Plastic Surgery · 58d

1 2 3 4

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Medacta International S.A. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Medacta International S.A.

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