Bone Cement with Gentamicin - India CDSCO Medical Device Registration
Bone Cement with Gentamicin is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000226_29a4b0588fbe33f190abd14d94a7d025_ff460ad6bb20a2c6895dee33db8c9e62. This device is marketed under the brand name CEMFIX. The license holder is EVOLUTIS INDIA PVT. LTD., and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
CEMFIX
License Holder
EVOLUTIS INDIA PVT. LTD.Device Class
Approving Authority
CDSCO
Product Information
It is indicated use as Bone cement in Arthroplasty procedure of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection.The cements are intended for use to affix a new prosthesis in the second phase of a two stage revision after the initial infection has been cleared.
