KNEE SYSTEM - India CDSCO Medical Device Registration

KNEE SYSTEM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000082_f8dac7e74bd66c9fc656cccd5b1c3beb_fad5b8e6ffdafef3a6368bac89f8aedf. This device is marketed under the brand name GENESIS II. The license holder is Smith & Nephew Healthcare Pvt. Ltd. ,501 to 509, B Wing, Dynasty Business Park, Andheri-Kurla Road, Andheri East, Tal -Andheri East ( Mumbai-Zone 5 ) ,Mumbai City Maharashtra ,400059 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

KNEE SYSTEM

UID: IMP/MD/2019/000082_f8dac7e74bd66c9fc656cccd5b1c3beb_fad5b8e6ffdafef3a6368bac89f8aedf

Brand Name

GENESIS II

License Holder

Smith & Nephew Healthcare Pvt. Ltd. ,501 to 509, B Wing, Dynasty Business Park, Andheri-Kurla Road, Andheri East, Tal -Andheri East ( Mumbai-Zone 5 ) ,Mumbai City Maharashtra ,400059 ,India

Device Class

Class D

Approving Authority

CDSCO

Product Information

1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. 5. Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (GENESIS II) are incompetent. 6. Hinge knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (GENESIS II) are absent or incompetent.

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Other Products from Smith & Nephew Healthcare Pvt. Ltd. ,501 to 509, B Wing, Dynasty Business Park, Andheri-Kurla Road, Andheri East, Tal -Andheri East ( Mumbai-Zone 5 ) ,Mumbai City Maharashtra ,400059 ,India

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