Eu Mdd
Eu Md Class 3
On The Market
🇩🇪 Germany
Biotech Sterile Knee Endoprosthesis Systems
Devices (same UDI-DI)
1
Certificates
2
Countries
6
Notified Bodies
2
Basic Information
- Primary DI
- D-4049852KN1DNUB
- Basic UDI-DI Code
- B-4049852KN1DNUB
- Reference
- 4049852KN1DN
- Device Types
-
Single use Sterile Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Biotech GmbH
Additional Description
Biotech Sterile Knee Endoprosthesis Systems is a knee replacement system comprising of 8 different subsystems which can be used for various types of knee replacement in cases of knee joint destruction. In case of knee fracture or significant abrasion (Osteoporosis), the knee joint is replaced with an implant based on surgical techniques. The implant is able to create a condition similar to the original function of the knee. The role of the knee joint is to create a load transfer between the femur and the tibia in a way that allows for controlled yet free movement.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P0909030101 | BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS |
| P0909030102 | BICOMPARTMENTAL PRIMARY IMPLANT UNCEMENTED FEMORAL COMPONENTS |
| P0909030103 | BICOMPARTMENTAL PRIMARY IMPLANT CEMENTABLE FEMORAL COMPONENTS |
| P090903020101 | BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED MOBILE BEARING TIBIAL PLATES |
| P090903020102 | BICOMPARTMENTAL PRIMARY IMPLANT UNCEMENTED MOBILE BEARING TIBIAL PLATES |
| P090903020103 | BICOMPARTMENTAL PRIMARY IMPLANT CEMENTABLE MOBILE BEARING TIBIAL PLATES |
| P090903020104 | BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FIXED BEARING TIBIAL PLATES |
| P090903020105 | BICOMPARTMENTAL PRIMARY IMPLANT UNCEMENTED FIXED BEARING TIBIAL PLATES |
| P090903020106 | BICOMPARTMENTAL PRIMARY IMPLANT CEMENTABLE FIXED BEARING TIBIAL PLATES |
| P090903020201 | BICOMPARTMENTAL PRIMARY IMPLANT MOBILE BEARING TIBIAL INSERTS |
| P090903020202 | BICOMPARTMENTAL PRIMARY IMPLANT FIXED BEARING TIBIAL INSERTS |
| P090903020301 | BICOMPARTMENTAL PRIMARY IMPLANT TIBIAL COMPONENTS, MONOBLOCK MADE OF POLYETHYLENE |
| P090903020399 | BICOMPARTMENTAL PRIMARY IMPLANT TIBIAL COMPONENTS, MONOBLOCK - OTHER |
| P0909040101 | UNICOMPARTMENTAL KNEE PROSTHESES FEMORAL COMPONENTS (UNICONDYLAR), CEMENTED |
| P0909040102 | UNICOMPARTMENTAL KNEE PROSTHESES FEMORAL COMPONENTS (UNICONDYLAR), UNCEMENTED |
| P090904020101 | MOBILE CEMENTED UNICOMPARTMENTAL PRIMARY IMPLANT TIBIAL PLATES |
| P090904020102 | MOBILE UNCEMENTED UNICOMPARTMENTAL PRIMARY IMPLANT TIBIAL PLATES |
| P090904020103 | FIXED CEMENTED UNICOMPARTMENTAL PRIMARY IMPLANT TIBIAL PLATES |
| P090904020104 | FIXED UNCEMENTED UNICOMPARTMENTAL PRIMARY IMPLANT TIBIAL PLATES |
| P090904020201 | MOBILE UNICOMPARTMENTAL KNEE PROSTHESES TIBIAL INSERTS |
| P090904020202 | UNICOMPARTMENTAL KNEE PROSTHESES TIBIAL INSERTS, FIXED |
| P090904020301 | KNEE PROSTHESES TIBIAL COMPONENTS, PREASSEMBLED, CEMENTED |
| P090904020302 | UNICOMPARTMENTAL KNEE PROSTHESES TIBIAL COMPONENTS, PREASSEMBLED, UNCEMENTED |
| P090904020401 | UNICOMPARTMENTAL KNEE PROSTHESES TIBIAL COMPONENTS, MONOBLOCK, MADE OF POLYETHYLENE |
| P090904020499 | UNICOMPARTMENTAL KNEE PROSTHESES TIBIAL COMPONENTS, MONOBLOCK - OTHER |
| P09090501 | REVISION KNEE PROSTHESES FEMORAL COMPONENTS |
| P090905020101 | REVISION KNEE PROSTHESES MOBILE BEARING TIBIAL PLATES |
| P090905020102 | REVISION KNEE PROSTHESES FIXED BEARING TIBIAL PLATES |
| P090905020201 | REVISION KNEE PROSTHESES MOBILE BEARING TIBIAL INSERTS |
| P090905020202 | REVISION KNEE PROSTHESES FIXED BEARING TIBIAL INSERTS |
| P090906 | KNEE PROSTHESES FOR LARGE RESECTIONS |
| P09090701 | FEMORAL TROCHLEA RESURFACING COMPONENTS |
| P0909070201 | PATELLAR COMPONENTS, MONOBLOCK |
| P0909070202 | PATELLAR COMPONENTS, MODULAR |
| P090908 | KNEE PROSTHESES SPACERS |
| P090999 | KNEE PROSTHESES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | No. 5-904-204-2103 | NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) | Expired |
| MDD Annex II (excluding section 4) | No. 5-903-200-2103 | NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) | Expired |
Available In Countries
🇨🇿 Czechia
🇩🇪 Germany
🇬🇷 Greece
🇭🇷 Croatia
🇭🇺 Hungary
🇹🇷 Türkiye
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