Total Joints System/ Knee Replacement System - India CDSCO Medical Device Registration

Total Joints System/ Knee Replacement System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000061_d9e7f8c89da46a21130f74eddf905435_000fd51ecd461fff0416f9f786cff9d7. This device is marketed under the brand name Fix/Mobile/Revision System And Tumor System. The license holder is SMIT MEDIMED PVT LTD, 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 Joints System/ Knee Replacement System

UID: MFG/MD/2019/000061_d9e7f8c89da46a21130f74eddf905435_000fd51ecd461fff0416f9f786cff9d7

Brand Name

Fix/Mobile/Revision System And Tumor System

License Holder

SMIT MEDIMED PVT LTD

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Intended Use / Indications: Total Knee Replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. Candidates for total knee replacement include elderly patients with severely painful and/or severely disabled joint resulting from Rheumatoid arthritis; Osteoarthritis; Knee ankylosis; other knee diseases which adapt to knee replacement

Class C

Bone Screw

Brand: Fix/Mobile/Revision System And Tumor System

SMIT MEDIMED PVT LTD

Class C

Brand: SMPL

Class A