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Hip Prosthesis, Total Hip Replacement PMMA - India CDSCO Medical Device Registration

Hip Prosthesis, Total Hip Replacement PMMA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000823_67e6a8f44b6ad917ccd8a7906dd33666_586a28e3bc1163ee628fce0ade3d523f. This device is marketed under the brand name Sterile. The license holder is ELECTRO MAGNETIC INDUSTRIES, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered
Class Class C
Hip Prosthesis, Total Hip Replacement PMMA
UID: MFG/MD/2023/000823_67e6a8f44b6ad917ccd8a7906dd33666_586a28e3bc1163ee628fce0ade3d523f

Brand Name

Sterile

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Total Hip Replacement (Sterile) is intended for use in the total hip arthroplasty and is intended for pressfit (Sterile) use. Total hip arthroplasty is intended to provide increase patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to sit and support the component. Total hip replacement is indicated in the following conditions. A).Non inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, rheumatoid arthritis or congenital hip dysplasia, and avascular necrosis. B).Correction of functional deformity. C). Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. D). Revision procedures where other treatment or devices have failed

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