Total Hip System - India CDSCO Medical Device Registration

Total Hip System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000076_08226695ea318b8832570f14edad039e_10401dcab348e10a170fdf694a8a2740. This device is marketed under the brand name REFLECTION. 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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CDSCO Registered

Class Class D

Total Hip System

UID: IMP/MD/2018/000076_08226695ea318b8832570f14edad039e_10401dcab348e10a170fdf694a8a2740

Brand Name

REFLECTION

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class D

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 non-inflammatory degenerative joint disease (REFLECTION) 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