Spacer for Knee - India CDSCO Medical Device Registration
Spacer for Knee is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000482_fc482d4b608f2877a03c666278859390_f462ef2580074faea5c642bc45ad38c1. This device is marketed under the brand name Rally AB Bone Cement . The license holder is Mn Solutions, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Rally AB Bone Cement
License Holder
Mn SolutionsDevice Class
Approving Authority
CDSCO
Product Information
Spacer-K is indicated for temporary use (Rally AB Bone Cement ) as an adjunct to total knee replacement (Rally AB Bone Cement ) in skeletally mature patients undergoing a two-stage procedure due to a septic process. Spacer-K is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (Rally AB Bone Cement ). It is particularly indicated for operations which present risks of or existing infections caused by organisms sensitive to Gentamicin
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