Eu Mdd Eu Md Class 3 On The Market 🇮🇳 India

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Devices (same UDI-DI)
1
Certificates
1
Countries
2
Notified Bodies
1

Basic Information

Primary DI
08902618005328
Basic UDI-DI Code
B-08902618005328
Reference
BPB22
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market

Additional Description

The Mobile bearing is constructed from UHMWPE (Ultrahigh molecular Weight Polyethylene). UHMWPE complies with the material standard ISO 5834-2, Type-2 / ASTM F648, fabricated form Type-2. The articular surface is constructed from the same common generating curve used to construct the femoral geometry in the frontal plane. The inferior portion of the bearing contains an integrally attached conical stem. An anterior recess is present in the bearing to clear the patellar tendon and prosthesis and a posterior notch is present to clear both soft and hard tissues that could possibly interfere with the bearing in deep flexion. Mobile Bearing is available in six sizes to match the femoral component size and it has four thicknesses from 0 through 7.5 mm in 2.5 mm increments. The Knee Mobile bearing component is supplied in sterile condition after being sterilised using Ethylene Oxide sterilization process.

CND Nomenclature Codes

Code Description
P090903020201 BICOMPARTMENTAL PRIMARY IMPLANT MOBILE BEARING TIBIAL INSERTS

Certificates

Type Number
MDD Annex II Section 4 11251-2017-CE-IND-NA-PS

Available In Countries

🇮🇹 Italy 🇹🇷 Türkiye

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