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Total Knee system - India CDSCO Medical Device Registration

Total Knee system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000063_ca0d7cf4e517dba316b1686c6427a26d_a2125d0a0dd71610ce34384e9a119863. This device is marketed under the brand name Stemmed Tibial Components & PCK Components. The license holder is Meril Healthcare Pvt. Ltd. ,Ground & First Floor, Survey No.173/4 and First Floor, H1-H3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi-396191 Gujarat, India. ,Valsad Gujarat ,396191 ,India, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.

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CDSCO Registered
Class Class C
Total Knee system
UID: MFG/MD/2018/000063_ca0d7cf4e517dba316b1686c6427a26d_a2125d0a0dd71610ce34384e9a119863

Brand Name

Stemmed Tibial Components & PCK Components

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Partial replacement of the articulation of the articulating surface of the knee when only one side of the joint is affected due to compartmental primary degenerative or post -traumatic degenerative disease, previous tibial condyle or pleateau fractures, deformity or revision of previous arthroplasty

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