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Total Knee Replacement System-Patella - India CDSCO Medical Device Registration

Total Knee Replacement System-Patella is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000070_cc771070d2e4d48998fae30eb972f10a_f633474413c62bbc36c7e0d16009c34e. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

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CDSCO Registered
Class Class C
Total Knee Replacement System-Patella
UID: IMP/MD/2020/000070_cc771070d2e4d48998fae30eb972f10a_f633474413c62bbc36c7e0d16009c34e

Brand Name

Antibiotic Simplex

Device Class

Class C

Approving Authority

CDSCO

Product Information

It is indicated in Painful, disabling joint disease of the Knee resulting from: degenerative arthritis, rheumatoid arthritis or posttraumatic arthritis, posttraumatic 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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