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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 - India CDSCO Medical Device Registration

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 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000634_86e07b57e0cb84d365b1354e1cd6aedd_1235feecc40cbf7d485fc0901a4262a0. 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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Class Class C
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
UID: MFG/MD/2022/000634_86e07b57e0cb84d365b1354e1cd6aedd_1235feecc40cbf7d485fc0901a4262a0

Brand Name

SUHRADAM ORTHO

License Holder

SUHRADAM ORTHO

Device Class

Class C

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Long: The SUHRADAM ORTHO’S proximal femoral nail is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high sub-trochanteric fractures.The SUHRADAM ORTHO’S Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include Diaphyseal fractures of the humeral shaft, Fractures of the proximal humerus, Proximal humeral fractures with diaphyseal extension, Impending pathologic fractures & Mal-unions and non-unions. The SUHRADAM ORTHO’S unreamed humeral nails are indicated for the treatment of fractures of proximal humerus. Recon Nails: The SUHRADAM ORTHO’S Recon Nail System is a fracture fixation device comprised of reconstruction nails and the related accessories such as washers, locking screws, set screws, end caps, and lag screws. The devices are intended to provide strong and stable internal fracture fixation with minimal soft tissue irritation of the tibia and femur. This device is utilized as an aid to healing, not as a substitute for normal intact bone and tissue. The SUHRADAM ORTHO’S Gamma Nail is indicated for use in fixation of femoral fractures occurring from the base of the femoral neck extending distally to a point proximal to intercondylar notch. Fracture types include basilar neck, intertrochanteric, sub-trochanteric fractures and femoralshaft fractures. The SUHRADAM ORTHO’S Elastic Intramedullary Nail System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is important. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones Intramedullary Nail Bolt used with Intramedullary Nail"

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