Revision Acetabular System - India CDSCO Medical Device Registration

Revision Acetabular System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000076_17a7e001140e58cd20b5a7e59f33b6e5_815c584d8fc32f25f9c869c12574b77c. 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

Revision Acetabular System

UID: IMP/MD/2018/000076_17a7e001140e58cd20b5a7e59f33b6e5_815c584d8fc32f25f9c869c12574b77c

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 degenerative joint disease or any of its composite diagnoses of osteoarthritis, a vascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.