Total Knee replacement System - India CDSCO Medical Device Registration
Total Knee replacement System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000070_a0c1490e13fe100fbde114482acdb003_4d3a7dc3bb8495c189107c3965990c30. This device is marketed under the brand name Antibiotic Simplex. The license holder is M/s Stryker India Private Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
Antibiotic Simplex
License Holder
M/s Stryker India Private Ltd.,Device Class
Approving Authority
CDSCO
Product Information
It is indicated for painful, disabling joint disease of the knee resulting from degenerative arthritis, rheumatoid arthritis or post- traumatic arthritis, post- traumatic loss of knee joint configuration and function , in moderate varus , valgus or flexion deformity in which the ligamentous structures can be returned to adequate function and stability and in revision of previous unsuccessful Knee replacement or other procedures
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Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Antibiotic Bone Cement(Antibiotic Bone Cement Simplex P )
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Total Knee Replacement System-Patella
Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
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Brand: Antibiotic Simplex
M/s Stryker India Private Ltd.,
Modular replacement System
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M/s Stryker India Private Ltd.,
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M/s Stryker India Private Ltd.,
Total Knee Replacement System-Patellar components
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M/s Stryker India Private Ltd.,
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