Hip System - Head - India CDSCO Medical Device Registration
Hip System - Head is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000172_bb1bed24fe1208aeb66b8d96841cd331_e4530ac1cf64b5e28662b41e92171468. This device is marketed under the brand name Marathon XLPE. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Marathon XLPE
License Holder
Johnson & Johnson Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total hip replacement is indicated in the following conditions: 1.A severely painful and/or disabled joint from osteoarthritis, trauma?c arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3.A cute trauma?c fracture of the femoral head or neck. 4.F ailed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5.Certain cases of ankylosis
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