Knee Replacement System- Sigma - Patella - - India CDSCO Medical Device Registration
Knee Replacement System- Sigma - Patella - is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000489_15aefac18a21e9a2b6e9eb4c8522ac30_1456c19997c41594431f6285dda274d4. 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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Brand Name
Global Advantage - Head
License Holder
Johnson & Johnson Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The P.F.C. SIGMA and P.F.C. Modular Knee System — Patella components are indicated for use in knee replacements for patients suffering from severe pain and disability due to permanent structural damage in the knee joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, or pseudo gout. This damage may also be the result of trauma or failed prior surgical intervention. The P.F.C. SIGMA and P.F.C. Modular Knee System — Patella components are indicated for use only with PMMA bone cement
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