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/2022/000634_da6ca8b727c2e798a03e5d677eec23d7_abdd51845b594d423bbefbe45049817f. This device is marketed under the brand name SUHRADAM ORTHO. The license holder is SUHRADAM ORTHO, 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

BONE SCREW

UID: MFG/MD/2022/000634_da6ca8b727c2e798a03e5d677eec23d7_abdd51845b594d423bbefbe45049817f

Brand Name

SUHRADAM ORTHO

License Holder

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

SUHRADAM ORTHO's Bone Screws -Washer , Wires are used in combination with plates are intended for fixation of various fractures, osteotomies, malunions, arthrodesis, replacement, reconstruction, correction, stabilization of various bones [clavicle, pelvis, scapula, long bone (SUHRADAM ORTHO), and small bone (metacarpals, metatarsals, phalanges] in general. The SUHRADAM ORTHO's Bone washer are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments

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INTRAMEDULLARY NAIL-"Nail system: The SUHRADAM ORTHO’S Tibial Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial mal-unions and non-unions. The tibial nails can be of Interlocking tibial nail, cannulated tibial nail and distal tip distal locking tibial nail types. The SUHRADAM ORTHO’S Retrograde/Ante grade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including supracondylar fractures, including those with intra-articular extension; ipsilateral hip/shaft fractures; ipsilateral femur/tibia fractures; femoral fractures in multiple trauma patients; fractures proximal to total knee arthroplasty; fractures distal to a hip implant; fractures in the morbidly obese; fractures in osteoporotic bone, impending pathologic fractures; and mal-unions and non-unions. The SUHRADAM ORTHO’S femoral nail is indicated for use in a variety of femoral fractures such as Comminuted fractures, Segmental fractures, Fractures with bone loss, Proximal and distal fractures, Non-unions, Sub-trochanteric fractures, Intertrochanteric fractures. The SUHRADAM ORTHO’S supracondylar intramedullary nails are intended for use in fixation of various types of fractures of supracondylar or distal region of the femur as well as for proximal fractures in conjunction with supracondylar fractures. Proximal Femoral Nail, Proximal Femoral Nail

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INTRAMEDULLARY NAIL-"Nail system: The SUHRADAM ORTHO’S Tibial Nail System is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post-isthmic fractures; and tibial mal-unions and non-unions. The tibial nails can be of Interlocking tibial nail, cannulated tibial nail and distal tip distal locking tibial nail types. The SUHRADAM ORTHO’S Retrograde/Ante grade Femoral Nail System is intended to stabilize fractures of the distal femur and the femoral shaft, including supracondylar fractures, including those with intra-articular extension; ipsilateral hip/shaft fractures; ipsilateral femur/tibia fractures; femoral fractures in multiple trauma patients; fractures proximal to total knee arthroplasty; fractures distal to a hip implant; fractures in the morbidly obese; fractures in osteoporotic bone, impending pathologic fractures; and mal-unions and non-unions. The SUHRADAM ORTHO’S femoral nail is indicated for use in a variety of femoral fractures such as Comminuted fractures, Segmental fractures, Fractures with bone loss, Proximal and distal fractures, Non-unions, Sub-trochanteric fractures, Intertrochanteric fractures. The SUHRADAM ORTHO’S supracondylar intramedullary nails are intended for use in fixation of various types of fractures of supracondylar or distal region of the femur as well as for proximal fractures in conjunction with supracondylar fractures. Proximal Femoral Nail, Proximal Femoral Nail

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