| EMDDB code |
21540
|
| Basic UDI-DI |
0705034a002486A
|
| Seadme klass |
Meditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
IIb
|
| Appliance |
-
|
| Device name (in Estonian) |
VIPER lülisambasüsteemi fenestreeritud kruviimplantaadid
|
| Device name (in English) |
Viper System Fenestrated Screw Implants
|
| Intended use (is Estonian) |
Lülisambasüsteemi VIPER fenestreeritud kruvid, kui neid kasutatakse koos lülisamba tsemendisüsteemiga CONFIDENCE SPINAL CEMENT SYSTEM™ või tsemendisüsteemidega VERTECEM™ V+, on mõeldud rindkere-/nimmelülide ja ristluulülide (T1–S2) posterioorseks fikseerimiseks fusiooni toetamisel vähenenud luukvaliteediga küpse luustikuga patsientidel. Ilma tsemendita kasutamisel tohib lülisambasüsteemi VIPER avadega kruvisid kasutada ainult piisava luukvaliteediga patsientidel. Kui kasutate lülisambasüsteemi VIPER avadega kruvisid ilma tsemendita, kehtib lülisambasüsteemi VIPER märgistus.
|
| Intended use (in English) |
The fenestrated screws of the VIPER System, when used with the CONFIDENCE SPINAL CEMENT SYSTEM™ or VERTECEM™ V+ Cement Systems, are intended for posterior fixation of the thoracolumbar and sacral spine (T1-S2) as an adjunct to fusion in skeletally mature patients with diminished bone quality. When used without cement, VIPER System fenestrated screws should only be used in patients with sufficient bone quality. When using the fenestrated screws of the VIPER System without cement, the VIPER System labeling applies.
|
| Type/model/article number |
List of products attached.
|
| Notified body |
2797
|
| Manufacturer |
Medos International SARL
|
| Authorised representative |
DePuy Ireland UC
|
| In register from |
01/31/2025
|
| Entry status |
Active
|
| Device comments, keywords |
MDR
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
