Total Hip Replacement
- UID
- MFG/MD/2021/000011_2468290d6412b3418085935bb21c1dad_f62713f4eb7a18d196399abc1a1761e3
- Device class
- Class D
- Brand name
- IMAGE
- License holder
- Image Ortho Surgical Pvt. Ltd.,
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Total Hip Replacement (IMAGE) is intended for use in the total hip arthroplasty and is intended for pressfit (IMAGE) 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.(IMAGE) Correction of function deformity. (IMAGE) Non inflammatory degenerative joint disease (IMAGE) including osteoarthritis, traumatic/Rheumatoid arthritis, congenital hip dysplasia and avascular necrosis. (IMAGE) Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement unmanaged by other procedures. (IMAGE) revision procedure when other devices are failed.
Total Hip Replacement is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000011_2468290d6412b3418085935bb21c1dad_f62713f4eb7a18d196399abc1a1761e3. This device is marketed under the brand name IMAGE. The license holder is Image Ortho Surgical Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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