Total Knee Replacement System-Patellar components
- UID
- IMP/MD/2020/000070_b047126753a94e25bf4b1cd8ae01f322_2e01e442a4478395acc7d51477e4abcb
- Device class
- Class C
- Brand name
- Antibiotic Simplex
- License holder
- M/s Stryker India Private Ltd.,
- Approving authority
- CDSCO
- Product information
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (Antibiotic Simplex), rheumatoid arthritis or post-traumatic arthritis. • Post-traumatic loss of knee joint configuration and function. • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. • Revision of previous unsuccessful knee replacement or other procedure. • Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
Total Knee Replacement System-Patellar components is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000070_b047126753a94e25bf4b1cd8ae01f322_2e01e442a4478395acc7d51477e4abcb. 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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