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CDSCO UID MFG/MD/2020/000216_f54a59945381c40b0ba68d90ba0651a8_f1e706aaf69a684cf43c961e70bbbdbe

Revision Knee Components

Agrosurg Irradiators (India) Pvt. Ltd.·Device Class Class C·India CDSCO·Brand: For Gamma Sterilization
Registration details
UID
MFG/MD/2020/000216_f54a59945381c40b0ba68d90ba0651a8_f1e706aaf69a684cf43c961e70bbbdbe
Device class
Class C
Brand name
For Gamma Sterilization
License holder
Agrosurg Irradiators (India) Pvt. Ltd.
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: • Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. •Correction of functional deformities. Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy. • Moderate valgus, varus, or flexion trauma. • Knee fractures untreatable by other methods • 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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About this record

Revision Knee Components is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000216_f54a59945381c40b0ba68d90ba0651a8_f1e706aaf69a684cf43c961e70bbbdbe. 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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