| EMDDB code |
21536
|
| Basic UDI-DI |
0603295a004408N
|
| Seadme klass |
Meditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
IIb
|
| Appliance |
-
|
| Device name (in Estonian) |
P.F.C. SIGMA distaalne (kombo) augmentatsioon; P.F.C. SIGMA tsemendiga posterioorne (kombo) augmentatsioon
|
| Device name (in English) |
P.F.C. SIGMA Distal augment (combo); P.F.C. SIGMA Posterior augment (combo) cemented
|
| Intended use (is Estonian) |
Põlve atroplastika on ette nähtud kahjustatud põlveliigese liigenduvate elementide asendamiseks, kui on tõendeid komponentide paigaldamiseks ja toestamiseks piisavalt tugeva luu olemasolust.
|
| Intended use (in English) |
Knee arthroplasty is intended to replace articulating elements of a damaged knee joint where there is evidence of sufficient sound bone to seat and support the components.
|
| Type/model/article number |
List of products attached.
|
| Notified body |
2797
|
| Manufacturer |
DePuy Ireland UC
|
| In register from |
01/30/2025
|
| Entry status |
Active
|
| Device comments, keywords |
MDR
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
