Medacta International SA
CH-MF-000033473 · Switzerland · Castel San Pietro
Medacta International SA is registered in the European database on medical devices as a manufacturer, with 8 486 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 5 558 |
|---|---|
| Class IIb | 2 922 |
| Class I | 6 |
Most frequent device types declared: Knee Cutting guide NextAR - not sterile, Knee Cutting guide TKA - not sterile, Knee Cutting guide TKA - sterile, Knee Pin positioner TKA - not sterile, Knee Single use tibial kit.
Among these devices, 5 564 are declared sterile, 2 928 implantable, 394 reusable.
Authorised representative in the Union: Medacta Italia srl.
Devices declared under this manufacturer
- MUST LINK Ø6 - ø5.5 rod Cross Con 48-66 - Sterile
- MUST MINI Rod Ti 3.5 x 95mm (ste)
- MUST Polyaxial Cann Screw Ø6x30 - Ø5.5/6
- MUST Polyaxial Cann Ti Screw Ø4.5x40 - Ø5.5/6
- MyKnee LBS FemCutBL_Assem -CT-GMK -RM- #3-STERILE
- MyKnee MIS FemDisCutBl-MRI-GMK-RL-#3
- MyKnee NextAR Eff FemDisCutBl_Ass-MRI-GMK-LM-#2+
- MyKnee PPS MIS TibCutBlock-MRI-GMK-RL-#5
- MyKnee U LBS FemCutBl_Ass-MRI-GMK-LL-#4+ ST
- MyKnee U STD FemDisCutBl-CT-GMK-LL-#2+
- MyKnee U STD TibCutBl-MRI-GMK-LL-#2
- MySpine LP drill pilot guide T02 STERILE
Showing 12 of 8 486 declared devices.
Catalogue references include 03.68.379, 03.68.763, 03.75.694, 04.01.10.0414, 11.10162, 24.2082.
European nomenclature codes declared: K01020114, P09070302, P091399, P09070301, V06010103, P09070199.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | MEDACTA INTERNATIONAL SA (CH) · FDA 3008110533 |
| Devices in EUDAMED | 8 486 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 8 486 |
|---|---|
| Found in the U.S. device database | 6 751 |
| Share | 79.6 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | MEDACTA INTERNATIONAL SA |
What it holds in Canada
| Licences on record | 54 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 33 |
| Class 3 devices | 21 |
| First licensed | 2009-07-15 |
Licence types: Device Family (43), System (10), Device Group Family (1).
Licensed under: ACETABULAR REAMERS, ADAPTORS, BROACHES, COMPRESSED AIR TUBING, DRILLS AND DRILL BITS, FLEXIBLE DRILL SHAFT.
North American profile: Both markets. Medacta International SA is registered in both the United States and Canada.