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Revision Knee Components - India CDSCO Medical Device Registration

Revision Knee Components is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000066_f54a59945381c40b0ba68d90ba0651a8_5ee36f13a948ba01f949d12068d94dd4. 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.

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.

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CDSCO Registered
Class Class C
Revision Knee Components
UID: MFG/MD/2022/000066_f54a59945381c40b0ba68d90ba0651a8_5ee36f13a948ba01f949d12068d94dd4

Brand Name

Stemmed Tibial Components & PCK Components

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, West Zone

Product Information

The Destiknee Stemmed Tibial Components/PCK components are designed to be used with Destiknee-Total Knee System, and is indicated for the following: โ€ข Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. โ€ขCorrection of functional deformities. Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. โ€ข Moderate valgus, varus, or flexion trauma. โ€ข Knee fractures untreatable by other methods โ€ข Revision surgery where sufficient bone stock and soft tissue integrity are present These Components are intended for cemented use only. This device is for single use only

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