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Total Knee System-Tibial Articular Surface [liner Metal backed]CR & PS(Evolve - Tibial Articular Surface [liner Metal backed]CR & PS ) - India CDSCO Medical Device Registration

Total Knee System-Tibial Articular Surface [liner Metal backed]CR & PS(Evolve - Tibial Articular Surface [liner Metal backed]CR & PS ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000063_bcd67331cdea9c52d8c7f04c5e4dc24d_821cf4e8a54ef8e098c1586a98e4cbd7. This device is marketed under the brand name PCK Components. The license holder is Meril Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered
Class Class C
Total Knee System-Tibial Articular Surface [liner Metal backed]CR & PS(Evolve - Tibial Articular Surface [liner Metal backed]CR & PS )
UID: MFG/MD/2018/000063_bcd67331cdea9c52d8c7f04c5e4dc24d_821cf4e8a54ef8e098c1586a98e4cbd7

Brand Name

PCK Components

Device Class

Class C

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: โ€ข Painful degenerative knee joint disease caused by: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. โ€ข Correction of functional deformities. โ€ข Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. โ€ข Moderate valgus, varus, or flexion trauma. โ€ข Knee fractures untreatable by other methods

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