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Prosthesis, Total Knee Replacement {SS} - India CDSCO Medical Device Registration

Prosthesis, Total Knee Replacement {SS} is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000203_f599c7220a64c58353169528732e0c7e_27b6f2bb1abe596aac2d4d1db57864e4. This device is marketed under the brand name Sterile. The license holder is PERFECT MEDICARE PRODUCTS, 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
Prosthesis, Total Knee Replacement {SS}
UID: MFG/MD/2020/000203_f599c7220a64c58353169528732e0c7e_27b6f2bb1abe596aac2d4d1db57864e4

Brand Name

Sterile

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Total Knee Replacement (Sterile) is intended to provide increased patient mobility and reduce pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. TKR may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for TKR outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom again in knee mobility may lead to an expectation of significant improvement in the quality of their lives. TKR is indicated for a severely painful and/or disabled joint from osteoarthritis, post- traumatic arthritis, rheumatoid arthritis or a failed previous implant

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