Bone Plate - India CDSCO Medical Device Registration
Bone Plate is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000274_3d18736f7e1d94ec1c52f33e2e890dda_4bc08d8026ccdb52b90b36a21e3c335d. 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
The bone plate is intended for internal fixation of fractures and reconstruction of bones including the Scapula, Olecranon, Humerus, Radius, Ulna, Pelvis, Distal, Tibia, Fibula, Hand and Foot in adults and for long bones in adolescents in whom the growth plates are fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extra-articular fractures, displaced fractures, osteotomies, non-unions and mal-unions. This system can be used for ventral, dorsal or orthogonal application
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