Hip System- Stem - India CDSCO Medical Device Registration
Hip System- Stem is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000454_44bbdef4463c173d8f27f0de9e6ffa12_ebece0135abdb2a4091b6966d17818c6. This device is marketed under the brand name Corail. The license holder is Johnson & Johnson Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Corail
License Holder
Johnson & Johnson Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
Corail AMT HA coated stems are intended for use in total and partial hip arthroplasty. The stems are intended only for uncemented use. Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Partial hip arthroplasty (Corail) is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem
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