| EMDDB code |
21688
|
| Basic UDI-DI |
0705034a002085W
|
| Seadme klass |
Meditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
IIb
|
| Appliance |
-
|
| Device name (in Estonian) |
VIPER (2) süsteemi üksik sisemine fikseerimiskruvi
|
| Device name (in English) |
VIPER (2) System Single inner set screw
|
| Intended use (is Estonian) |
Lülisambasüsteem VIPER on mõeldud rindkere-/nimmelülide ja ristluulülide (T1–S2) posterioorseks fikseerimiseks fusiooni toetamisel küpse luustikuga täiskasvanutel ja lapspatsientidel. See on mõeldud ajutiseks seespidiseks toetamiseks ja fikseerimiseks fusioonimassi konsolideerumise, luumurru paranemise või lülisambakasvajaga patsientidel seisundi stabiliseerumise ajal. Lülisabasüsteemi VIPER võib kasutada koos luusiiriku või luusiiriku materjaliga.
|
| Intended use (in English) |
The VIPER System is intended for posterior fixation of the thoracolumbar and sacral spine (T1-S2) as an adjunct to fusion in skeletally mature and pediatric patients. It is intended to provide temporary internal support and fixation while the fusion mass is consolidating, the fracture is healing, or the stabilization is palliating in patients with spinal tumor. The VIPER System may be used with bone graft or bone graft material.
|
| Type/model/article number |
186715000S, 186715000
|
| Notified body |
2797
|
| Manufacturer |
Medos International SARL
|
| Authorised representative |
DePuy Ireland UC
|
| In register from |
03/12/2025
|
| Entry status |
Active
|
| Device comments, keywords |
MDR
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
