Total Knee System - India CDSCO Medical Device Registration

Total Knee System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000379_ed840676bf82becf25e74dd89cf95c2e_8ce48e724e76b34ce145fe30f517f88c. 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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CDSCO Registered

Class Class C

Total Knee System

UID: IMP/MD/2019/000379_ed840676bf82becf25e74dd89cf95c2e_8ce48e724e76b34ce145fe30f517f88c

Brand Name

Freedom

License Holder

Meril Life Sciences India Pvt. Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

It is indicated for patients with severe knee pain and disability due to- 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;All components are indicated for cemented application only.