Total Knee Replacement System
- UID
- IMP/MD/2020/000112_34c2e41e8e18584bcde6363d92a64ef3_1d5c0e2b6d902b0077d06d81e9793d4d
- Device class
- Class C
- Brand name
- Total Knee Replacement
- License holder
- Stryker India Pvt. Ltd.,
- Approving authority
- CDSCO
- Product information
- Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (Total Knee Replacement), 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 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000112_34c2e41e8e18584bcde6363d92a64ef3_1d5c0e2b6d902b0077d06d81e9793d4d. This device is marketed under the brand name Total Knee Replacement. The license holder is Stryker India Pvt. Ltd.,, and it is classified as Device Class Class C. The approving authority is CDSCO.
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