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
08902618005021
Basic UDI-DI Code
B-08902618005021
Reference
BPFR2
Device Types
Single use Sterile
Regulation
Eu Mdd
Classification
Eu Md Class 3
Status
On The Market

Additional Description

Constructed of Co-Cr alloy which complies with the material standard ISO 5832-4 / ASTM F75.Cemented version has to be used with bone cement for fixing the component with the bone. The superior surface of the femoral component contains twin fixation pins. The articular geometry, composed of two different radii, is swept around a series of parallel axes to form the profile in the sagittal plane. Therefore, each condyle and the anterior surface are composed of two convex and one, central concave surfaces. This configuration allows for congruity to be maintained during Valgus-Varus tilts and patellar tilts. The femoral sulcus is a deep, groove that accommodates congruent, anatomic, patellar prosthesis. The femoral component is available in six sizes, with separate versions for the right and left leg. The Knee Femoral component is supplied in sterile condition after being sterilised using the Ethylene Oxide sterilization process

CND Nomenclature Codes

Code Description
P0909030101 BICOMPARTMENTAL PRIMARY IMPLANT CEMENTED FEMORAL COMPONENTS

Certificates

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

Available In Countries

🇮🇹 Italy 🇹🇷 Türkiye

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