Joint Replacement Prosthesis
- UID
- MFG/MD/2023/000585_d56c3b0f426147c12a3bec35f2c2d830_f38ccf2acdca85f5333d3eec2c00765b
- Device class
- Class D
- Brand name
- Zenium
- License holder
- Komal Health Care Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, West Zone
- Product information
- The Zenium BiPolar System is intended for use in combination with a Komal Healthcare Femoral Stem for primary or revision hemiarthroplasty of the hip, with/without the use of bone cement, for treatment of the following conditions: • Femoral neck and trochanteric fractures of theproximal femur • Osteonecrosis of the femoral head • Revision procedures where other devices or treatments for these indications have failed.
Joint Replacement Prosthesis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000585_d56c3b0f426147c12a3bec35f2c2d830_f38ccf2acdca85f5333d3eec2c00765b. This device is marketed under the brand name Zenium. The license holder is Komal Health Care Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, West Zone.
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