Leforte System
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
- 08809265150299
- Basic UDI-DI Code
- B-08809265150299
- Reference
- 12-CD-008
- Device Types
-
Single use Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2b
- Status
- On The Market
- Manufacturer
- Jeil Medical Corporation
Additional Description
The LeForte System are comprised of a variety of shapes and sizes, designed and intended for use in selective trauma of the mid-face; reconstruction procedures; and selective orthognathic surgery of the maxilla and chin. The plates shape includes straight, Y, Z, curved, square, L(Left/Right), T, X, H, mesh and etc. Plates are manufactured from titanium(ASTM F67) and Screw are manufactured from titanium alloy (ASTM F136). The Plate & Screw are provided non-sterile and package in a pouch and must be sterilized by steam prior to use. The recommended plate & screw combination are as follows;
CND Nomenclature Codes
| Code | Description |
|---|---|
| P09120503 | OSTEOSYNTHESIS SCREW-PLATE SYSTEMS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | KR19/81826303 | DNV Product Assurance AS | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2b) and regulation (EU MDD).