GOLD ORTOPEDİ 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-8680419823357A9
- Basic UDI-DI Code
- B-8680419823357A9
- Reference
- 11082-10046
- Device Types
-
Single use Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- GOLD ORTOPEDİ SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Additional Description
It is indicated for fixation of complicated calcaneus fractures, calcaneus comminuted fractures and osteotomies. Locked lateral calcaneus plate is available with options 78 mm and 95 mm length and 18 and 20 holes; locked calcaneus Y plate with options 46 mm, 60 mm, 70 mm lenght and 8 holes; calcaneus F plate with options 46 mm, 60 mm, 70 mm lenght and 11, 14 holes; right and left options are available.Calcaneus plates are produced from ISO 5832-2 TiGr3 (ASTM F 67) material and used with Ø 4.0 mm locked spongiosis, Ø 4.0 mm spongiosis screw and Ø3.5 locked and cortical screw.
CND Nomenclature Codes
| Code | Description |
|---|---|
| P09120599 | BONE FIXATION PLATES - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1984-MDD-16-417 | Kiwa Belgelendirme Hizmetleri A.Ş. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).