ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- D-8680941248246AE
- Basic UDI-DI Code
- B-8680941248246AE
- Reference
- R.7039-1013
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Zimed Medikal Sanayi ve Ticaret Limited Şirketi
Additional Description
It is used as a binder in Total Knee Prosthesis to ensure that patients with suitable body anatomy have a wider range of knee flexion. It has the function of protecting the posterior cruciate ligaments (C-R) or cutting the posterior cruciate ligaments (P-S) and has a hyperflex feature that allows full flexion of 140-150°. Hyperflex insert and insert are identical in design. This inner component is produced from Ultra High Molecular Weight Polyethylene (UHMWPE) material.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P09090501 | REVISION KNEE PROSTHESES FEMORAL COMPONENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 1984-MOD-11-130 | Kiwa Belgelendirme Hizmetleri A.Ş. | Expired |
| MDD Annex II (excluding section 4) | 1984-MDD-11-129 | Kiwa Belgelendirme Hizmetleri A.Ş. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).