Knee Replacement System-Femoral - India CDSCO Medical Device Registration
Knee Replacement System-Femoral is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000556_ea8ef357146176f952d311ecdb7ac72b_285477b8625bc833f8e664188f758827. This device is marketed under the brand name Sigma PS. 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
Sigma PS
License Holder
Johnson & Johnson Private LimitedDevice Class
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 a gain in knee mobility may lead to an expectation of significant improvement in the quality of their lives
Knee Replacement System-Femoral
Brand: Sigma PS
Johnson & Johnson Private Limited
Knee Replacement System-Tibial Component
Brand: Sigma PS
Johnson & Johnson Private Limited
Knee Replacement System-Rod
Brand: Sigma PS
Johnson & Johnson Private Limited
Knee Replacement System-Stem
Brand: Sigma PS
Johnson & Johnson Private Limited
Knee Replacement System-Tibial Wedge
Brand: Sigma PS
Johnson & Johnson Private Limited
Knee Replacement System-Tibial tray
Brand: Sigma PS
Johnson & Johnson Private Limited
Knee Replacement System-Tibial Tray
Brand: Sigma PS
Johnson & Johnson Private Limited
Knee Replacement System-Tibial Tray
Brand: Sigma PS
Johnson & Johnson Private Limited
Knee Replacement System-Femoral Stem Bolt
Brand: Sigma PS
Johnson & Johnson Private Limited
Knee Replacement System-Femoral Stem
Brand: Sigma PS
Johnson & Johnson Private Limited
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