Hip Prosthesis, Total Hip Replacement {UHMWPE} - India CDSCO Medical Device Registration

Hip Prosthesis, Total Hip Replacement {UHMWPE} is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000203_54d7ee771ba23441c5e8e1daf4a96921_574826749064f2318de72ae4c01368ac. This device is marketed under the brand name Sterile. The license holder is PERFECT MEDICARE PRODUCTS, 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 {UHMWPE}

UID: MFG/MD/2020/000203_54d7ee771ba23441c5e8e1daf4a96921_574826749064f2318de72ae4c01368ac

Brand Name

Sterile

License Holder

PERFECT MEDICARE PRODUCTS

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 press fit (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 components. 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

Class C

Prosthesis, Total Knee Replacement UHMWPE

Brand: Sterile

ELECTRO MAGNETIC INDUSTRIES

Class C

Brand: Sterile

Class C