Cementless Femoral Components - India CDSCO Medical Device Registration
Cementless Femoral Components is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000379_451432e3667f524b0b113d0897f19f48_5e068edb00cbb213ebd3551d11662dad. This device is marketed under the brand name Freedom. The license holder is Meril Life Sciences India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Freedom
License Holder
Meril Life Sciences India Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
The Freedom Cementless Femoral Components are designed to be used as a part of the Freedom Total Knee System, and is indicated for - Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, Correction of functional deformities, Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy, Moderate valgus, varus, or flexion trauma, Knee fractures untreatable by other methods, Revision surgery where sufficient bone stock and soft tissue integrity are present;Cementless Femoral components with porous coating are indicated for cemented and cementless biological fixation application
