Modular Femoral Heads - India CDSCO Medical Device Registration
Modular Femoral Heads is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000347_0923a4706c0442786369cd24254a79fd_f9467d937eeedf671d2a77e46a6abdb1. This device is marketed under the brand name C-Stem. 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
C-Stem
License Holder
Johnson & Johnson Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The Femoral Head is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post traumatic arthritis, collagen disorders, avascular necrosis and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstructive techniques
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