Knee Replacement System(Sigma - Femoral )
- UID
- IMP/MD/2019/000489_ce07cbfbf6c9005b9312d3b4c13c3c7d_f8c237274215f5bd85da2f50d0e53233
- Device class
- Class D
- Brand name
- Global Advantage - Head
- License holder
- Johnson & Johnson Private Limited
- Approving authority
- CDSCO
- Product information
- Total or unicompartmental knee arthroplasty is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Total or unicompartmental knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total or unicompartmental knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom again in knee mobility may lead to an expectation of significant improvement in the quality of their lives
Knee Replacement System(Sigma - Femoral ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000489_ce07cbfbf6c9005b9312d3b4c13c3c7d_f8c237274215f5bd85da2f50d0e53233. This device is marketed under the brand name Global Advantage - Head. 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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