HIP SYSTEM - India CDSCO Medical Device Registration
HIP SYSTEM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000082_09b19911eb5f70e2882c31242bd3a769_79d65fe8fe3ea0a8fc4cec6be582e63e. This device is marketed under the brand name TANDEM BIPOLAR. The license holder is Smith & Nephew Healthcare Pvt. Ltd. ,501 to 509, B Wing, Dynasty Business Park, Andheri-Kurla Road, Andheri East, Tal -Andheri East ( Mumbai-Zone 5 ) ,Mumbai City Maharashtra ,400059 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
TANDEM BIPOLAR
Device Class
Approving Authority
CDSCO
Product Information
1. Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis; 2. Rheumatoid arthritis; 3. Arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis; 4. Revision procedures where other treatments have failed; and 5. Treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.
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