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 MFG/MD/2020/000216_4b570bbbb8ab6449ebfa8268ad893b86_d1021b8b468765d3ff1ec05c410abae1. This device is marketed under the brand name For Gamma Sterilization. The license holder is Agrosurg Irradiators (India) Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.

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CDSCO Registered

Class Class C

Total Knee system

UID: MFG/MD/2020/000216_4b570bbbb8ab6449ebfa8268ad893b86_d1021b8b468765d3ff1ec05c410abae1

Brand Name

For Gamma Sterilization

License Holder

Agrosurg Irradiators (India) Pvt. Ltd.

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

The Total Knee System is indicated for replacement of total knee or knee components for patients with severe knee pain and disability due to: • Painful degenerative knee joint disease caused by: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Correction of functional deformities. • Post-traumatic loss of knee joint contour, particularly when there is patella femoral erosion, dysfunction or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable by other methods