Synthes GmbH
CH-MF-000013345 · Switzerland · Oberdorf
Synthes GmbH is registered in the European database on medical devices as a manufacturer, with 31 944 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIb | 23 358 |
|---|---|
| Class IIa | 8 580 |
| Class I | 6 |
Most frequent device types declared: Cortex Screw Stainless Steel, Cortex Screw TAN, Cortex Screw TiCP, Headless Compression Screws HCS TAN, MatrixMANDIBLE Screws.
Among these devices, 13 555 are declared sterile, 23 363 implantable, 2 943 reusable, 354 active.
Authorised representative in the Union: DePuy Ireland UC.
Devices declared under this manufacturer
- DHS, DCS
- LCP
- MATRIX
- MAXFRAME
- MatrixMANDIBLE
- MatrixMIDFACE
- PHILOS
- STARDRIVE
- SYNMESH
- Synthes Cutting Tools
- USS Fracture
- VA LCP
Showing 12 of 31 944 declared devices.
Catalogue references include 02.424.150TS, 04.111.651S, 04.227.265S, 04.503.648.01S, 201.370, 397.810.
European nomenclature codes declared: P09120601, P09120501, P09120603, L091001, Z12011399, P09070302.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Synthes GMBH (CH) · FDA 3000270450 |
| Devices in EUDAMED | 31 944 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 30 488 |
|---|---|
| Found in the U.S. device database | 4 734 |
| Share | 15.5 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SYNTHES GMBH |
What it holds in Canada
| Licences on record | 42 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 25 |
| Class 3 devices | 17 |
| First licensed | 1999-09-16 |
Licence types: System (18), Device Family (17), Single Device (5), Device Group Family (2).
Licensed under: EXTERNAL FIXATION - STAINLESS STEEL, CERVICAL FIXATION SYSTEM, EXTERNAL FIXATION - STAINLESS STEEL, SYNCAGE-C INTERVERTEBRAL FUSION SYSTEM, CONTACT FUSION CAGE, LCP TITANIUM METAPHYSEAL PLATES.
North American profile: Both markets. Synthes GmbH is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
G70 056032 0143 | issued | 2029-12-19 |