Total Knee Replacement System
- UID
- MFG/MD/2019/000214_34c2e41e8e18584bcde6363d92a64ef3_26bf76ff30bc0a576b551cc5fe2fd4b5
- Device class
- Class C
- Brand name
- Altius
- License holder
- TTK HEALTHCARE LIMITED (ORTHO DIVISION)
- Approving authority
- Central Drug Standard Control Organisation, South Zone
- Product information
- Model Name: a.Buechel-Pappas High Flex Total Knee Replacement System, b. Buechel-Pappas High Flex Total Knee Replacement System – Mark IV - Total Knee Replacement System is intended to provide primary or revision options to the surgeons to reduce or eliminate pain, restore motion, and/or correct deformity. Model Name : c. Buechel-Pappas Revision Knee Replacement System-i. Co-Cr Mobile Bearing Revision Knee – Cemented -This Buechel-Pappas (Altius) Revision Knee Replacement System is intended to provide primary or revision options to the surgeon to correct severe deformity and/or reduce or eliminate pain, restore motion, and/or correction of previously failed joint replacement procedures, in case where additional component stabilization by means of a stem is required. ii. Co-Cr Hinge Knee – Cemented and iii. Titanium Hinge Knee – Cemented-This Buechel-Pappas Revision Knee Replacement System is intended to provide primary or revision options to the surgeon to correct severe deformity and/or reduce or eliminate pain, restore motion, and/or correction of previously failed joint replacement procedures in the absence of viable collateral ligaments
Total Knee Replacement System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000214_34c2e41e8e18584bcde6363d92a64ef3_26bf76ff30bc0a576b551cc5fe2fd4b5. This device is marketed under the brand name Altius. The license holder is TTK HEALTHCARE LIMITED (ORTHO DIVISION), and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.
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