CDSCO UID IMP/MD/2018/000445_fe2aab42d294ab713b1f6619411cb39d_6ceb53947555e2a112d85e431fac7545
Hip System
M/s Zimmer India Pvt. Ltd·Device Class Class C·India CDSCO·Brand: Coonrad/ Morrey Total Elbow - Ulnar Component
Registration details
- UID
- IMP/MD/2018/000445_fe2aab42d294ab713b1f6619411cb39d_6ceb53947555e2a112d85e431fac7545
- Device class
- Class C
- Brand name
- Coonrad/ Morrey Total Elbow - Ulnar Component
- License holder
- M/s Zimmer India Pvt. Ltd
- Approving authority
- CDSCO
- Product information
- A. This device is indicated for total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, non-union of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high sub capital fractures and comminuted femoral neck fractures in the aged; non-union of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected.,knee system(Coonrad/ Morrey Total Elbow - Ulnar Component)-The device indications are the following: • Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. • The salvage of previously failed surgical attempts (Coonrad/ Morrey Total Elbow - Ulnar Component). • History of patellar dislocation or patella fracture. • Dysplasia-induced degeneration. • This device is intended for cemented use only
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About this record
Hip System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000445_fe2aab42d294ab713b1f6619411cb39d_6ceb53947555e2a112d85e431fac7545. This device is marketed under the brand name Coonrad/ Morrey Total Elbow - Ulnar Component. The license holder is M/s Zimmer India Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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