TOTAL HIP REPLACEMENT - ACETABULAR CUP, FEMORAL STEM - India CDSCO Medical Device Registration

TOTAL HIP REPLACEMENT - ACETABULAR CUP, FEMORAL STEM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000415_deaeb6d9717f06253b2f36899218a11e_e3e5932808a4e22d157700481b1466e3. This device is marketed under the brand name SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES. The license holder is M/s Emporis Implants And Surface Treatment, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered

Class Class D

TOTAL HIP REPLACEMENT - ACETABULAR CUP, FEMORAL STEM

UID: MFG/MD/2022/000415_deaeb6d9717f06253b2f36899218a11e_e3e5932808a4e22d157700481b1466e3

Brand Name

SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES

License Holder

M/s Emporis Implants And Surface Treatment

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Total Hip Replacement (SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES) isintended for use in the total hip arthroplasty and is intended for press fit (SHARMA, SPCPL, DKSORTHO, DKSORTHO MEDICAL DEVICES) 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.