Acetabular Shells - India CDSCO Medical Device Registration
Acetabular Shells is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000051_4aea04ee1de12d40ef9ed0b6a9770dcf_813378364640323c9c8b84335130d671. This device is marketed under the brand name R3. 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
R3
Device Class
Approving Authority
CDSCO
Product Information
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (R3) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracturedislocation of the hip; and correction of deformity
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