Endoprosthesis - India CDSCO Medical Device Registration
Endoprosthesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000274_4946a93329f923ef34f9cdc2ca91b210_9708bc5cdd6232ae8735bd7b7a1819b1. This device is marketed under the brand name HARDIK / ORTHOX. The license holder is Hardik International Private Limited, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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Brand Name
HARDIK / ORTHOX
License Holder
Hardik International Private LimitedDevice Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
The Orthopaedics Endoprostheses are used as a hemi arthroplasty for the following indications: • Femoral neck fractures, • Idiopathic avascular necrosis, • Nonunions, The patient’s acetabular bone stock must be adequate to support articulation with the head of the endoprosthesis End prosthesis Implant system consists of a variety of shapes and sizes , Austin Moore Hip Prosthesis , Thompson Hip Prosthesiss. The Austin-Moore and Thompson Endoprosthesis systems used for the treatment of proximal femoral manufactured by SS 316L material grade a wide range of head sizes and stem designs are available to accommodate the needs of individual patient anatomy for better alignment an as per fracture
Endoprosthesis
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