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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 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.

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
UID: MFG/MD/2019/000214_34c2e41e8e18584bcde6363d92a64ef3_26bf76ff30bc0a576b551cc5fe2fd4b5

Brand Name

Altius

Device Class

Class C

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 โ€“ 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 โ€“ 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 โ€“ Cemented and iii. Titanium Hinge Knee โ€“ 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

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