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

Prosthesis, Total Knee Replacement {TITANIUM ALLOY } is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2023/000823_2263902c553fd73f41ae7e6288bf03a8_94361d39183b24713e00f0e16eeba099. This device is marketed under the brand name Sterile. The license holder is ELECTRO MAGNETIC INDUSTRIES, 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 {TITANIUM ALLOY }

UID: MFG/MD/2023/000823_2263902c553fd73f41ae7e6288bf03a8_94361d39183b24713e00f0e16eeba099

Brand Name

Sterile

License Holder

ELECTRO MAGNETIC INDUSTRIES

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 damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. TKR may be consider for younger patients if, in the opinion of the surgeon, an unequivocal indication for TKR outweighs, the risk associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patient 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 disable joint from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis or a failed previous implant

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Prosthesis, Total Knee Replacement {SS}

Brand: Sterile

ELECTRO MAGNETIC INDUSTRIES

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

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

Prosthesis, Total Knee Replacement {SS}

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