Hip System - Acetabular Cup - India CDSCO Medical Device Registration
Hip System - Acetabular Cup is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000230_b76302540cc83f90fb7dcc9b0452d0c2_be501a387eedfadba6d4d37574d33f21. This device is marketed under the brand name POLARCUP. 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 D. The approving authority is CDSCO.
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Brand Name
POLARCUP
Device Class
Approving Authority
CDSCO
Product Information
POLARCUP- Advanced degeneration of the hip joint as result of osteoarthritis, avascular necrosis, posttraumatic arthritis, or rheumatoid arthritis, Femoral neck fracture or proximal fracture of the hip joint Conditions resulting from previous operations of the hip joint, such as failed total hip prosthesis. POLARCUP/REDAPT™ construct Complex primary hip joint arthroplasty and hip joint revision arthroplasty
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