Bone Screw - India CDSCO Medical Device Registration
Bone Screw is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000274_34f5cf5637c17f0474ebe7d8d7cfcaeb_03b56236cb6f1ab4b49dab2f43642c5b. This device is marketed under the brand name HARDIK / ORTHOX. The license holder is Hardik International Private Limited, and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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Brand Name
HARDIK / ORTHOX
License Holder
Hardik International Private LimitedDevice Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
Bone Screw is intended for internal fixation of fractures and reconstruction of bones including the Humerus, Tibia, Fibula, Hand and Foot in adults and for long bones in adolescents. Bone Screws fasten plates to bone, maintain bone fragments in their relative position, or hold together fragments of bone (HARDIK / ORTHOX). They vary according to the manner in which they are inserted into bone, their function, size, the type of bone they are intended for, and the manner in which they couple with the screw driver (HARDIK / ORTHOX)
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