Total Knee system
- UID
- MFG/MD/2018/000063_ca0d7cf4e517dba316b1686c6427a26d_821cf4e8a54ef8e098c1586a98e4cbd7
- Device class
- Class C
- Brand name
- Stemmed Tibial Components & PCK Components
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- 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 patellofemoral erosion, dysfunction or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable by other methods
Total Knee system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000063_ca0d7cf4e517dba316b1686c6427a26d_821cf4e8a54ef8e098c1586a98e4cbd7. This device is marketed under the brand name Stemmed Tibial Components & PCK Components. The license holder is Meril Healthcare Pvt. Ltd. ,Ground & First Floor, Survey No.173/4 and First Floor, H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi-396191 Gujarat, India. ,Valsad Gujarat ,396191 ,India, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.