CDSCO UID IMP/MD/2023/001059_e78bed436018a6937fba562951e00125_acf1d0797061d8bad11c21032b57f5c2

Acetabular Liners

Smith & Nephew Healthcare Pvt. Ltd·Device Class Class D·India CDSCO·Brand: R3
Registration details
UID
IMP/MD/2023/001059_e78bed436018a6937fba562951e00125_acf1d0797061d8bad11c21032b57f5c2
Device class
Class D
Brand name
R3
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; fracture-dislocation of the hip; and correction of deformity.
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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
Class D
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About this record

Acetabular Liners is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001059_e78bed436018a6937fba562951e00125_acf1d0797061d8bad11c21032b57f5c2. This device is marketed under the brand name R3. The license holder is Smith & Nephew Healthcare Pvt. Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO.

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