Total Knee System - India CDSCO Medical Device Registration
Total Knee System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000146_ed840676bf82becf25e74dd89cf95c2e_5f4b62819e2caca732619ce7d24c5d19. This device is marketed under the brand name Advance® and Advance Stature®. The license holder is MicroPort Scientific India Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Advance® and Advance Stature®
License Holder
MicroPort Scientific India Pvt. Ltd.,Device Class
Approving Authority
CDSCO
Product Information
It is intended for use in total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients.MicroPort Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
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