Eu Mdd Eu Md Class 2b On The Market 🇰🇷 South Korea

Leforte System

Jeil Medical Corporation · 🇰🇷 South Korea
Devices (same UDI-DI)
1
Certificates
1
Countries
1
Notified Bodies
1

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

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
MDD Annex II (excluding section 4) KR19/81826303

Available In Countries

🇪🇸 Spain

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