Revision Femoral System - India CDSCO Medical Device Registration

Revision Femoral System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000076_deb5727e5944533cf78af4e20d0a47fa_846660215694dbcde07a483ed8098a19. 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 Femoral System

UID: IMP/MD/2018/000076_deb5727e5944533cf78af4e20d0a47fa_846660215694dbcde07a483ed8098a19

Brand Name

REFLECTION

License Holder

Smith & Nephew Healthcare Pvt. Ltd.

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Smith & Nephew Femoral Hip Stems are intended for hip arthroplasty in skeletally mature patients with the following indications. The REDAPT Sleeveless Monolithic Femoral Stems are intended for use without bone cement. 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, avascular 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