CDSCO UID MFG/MD/2022/000066_4b570bbbb8ab6449ebfa8268ad893b86_d1021b8b468765d3ff1ec05c410abae1
Total Knee system
M/s AKSHAR GAMMA STERILES LLP·Device Class Class C·India CDSCO·Brand: Stemmed Tibial Components & PCK Components
Registration details
- UID
- MFG/MD/2022/000066_4b570bbbb8ab6449ebfa8268ad893b86_d1021b8b468765d3ff1ec05c410abae1
- Device class
- Class C
- Brand name
- Stemmed Tibial Components & PCK Components
- License holder
- M/s AKSHAR GAMMA STERILES LLP
- 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
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About this record
Total Knee system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000066_4b570bbbb8ab6449ebfa8268ad893b86_d1021b8b468765d3ff1ec05c410abae1. This device is marketed under the brand name Stemmed Tibial Components & PCK Components. The license holder is M/s AKSHAR GAMMA STERILES LLP, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, West Zone.
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