CDSCO UID MFG/MD/2022/000066_f54a59945381c40b0ba68d90ba0651a8_5ee36f13a948ba01f949d12068d94dd4
Revision Knee Components
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_f54a59945381c40b0ba68d90ba0651a8_5ee36f13a948ba01f949d12068d94dd4
- 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 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/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.
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