HEMl-ENDOPROSTHESIS - India CDSCO Medical Device Registration
HEMl-ENDOPROSTHESIS is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000178_0e8ee9abde75a73ec12b1f1eb56d65f4_f7ded49184070ed70f3b06a168210b39. The license holder is Yogeshwar Implants (I) Pvt Ltd, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.
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License Holder
Yogeshwar Implants (I) Pvt LtdDevice Class
Approving Authority
Central Drug Standards Control Organization, West Zone
Product Information
The YIPL Hemi Endoprosthesis are intended to be used by qualified and trained orthopaedic surgeons to carry out a partial or 'hemi' replacement of the femoral head of the hip joint in cases involving degenerative or traumatic changes to the femoral head, where there is x-ray evidence of a satisfactory acetabulum and sufficient bone in the femoral neck to seat the prosthesis with or without bone cement. These devices are meant to bear load while in use and are subjected to various mechanical forces. The extent to which the device would withstand these forces is limited by the operating surgeon achieving appropriate restoration of hip biomechanics and periarticular soft tissues.
