Silony Medical GmbH
DE-MF-000006463 · Germany · Leinfelden-Echterdingen
Silony Medical GmbH is registered in the European database on medical devices as a manufacturer, with 822 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 822 |
|---|
Among these devices, 2 are declared sterile, 783 reusable.
Devices declared under this manufacturer
- All Systems
- FAVO S-TLIF
- Oyster ACIF
- ROCCIA ACIF
- ROCCIA MultiLIF, ALIF, TLIF
- VERTICALE
- VERTICALE Cervical
- VERTICALE SI/Triangular Fixation
Showing 12 of 822 declared devices.
Catalogue references include FI-4020.1, FI-4050, RI-2090, RI-T10281105, RI-T104015, VI-0940.1.
European nomenclature codes declared: L091099, L091199, L091002, L091001, L0901, L0399.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | SILONY MEDICAL GMBH (DE) · FDA 3013422236 |
| Devices in EUDAMED | 822 |
| Country of registration | Germany |
Device-level evidence
| Devices with a numeric GTIN | 822 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | SILONY MEDICAL GMBH |
What it holds in Canada
| Licences on record | 5 |
|---|---|
| Currently active | 0 |
| Class 3 devices | 5 |
| First licensed | 2019-12-20 |
Licence types: System (4), Device Family (1).
Licensed under: STALIF L, STALIF C, STALIF C-TI, MIDLINE II-TI, STALIF C FLX.
North American profile: Both markets. Silony Medical GmbH is registered in both the United States and Canada.