CDSCO UID MFG/MD/2022/000634_7f7e6aefdb08e44a88c70decf2b1de8d_e8958e340ce10193aae44edd58d66069
Spine Implant
SUHRADAM ORTHO·Device Class Class C·India CDSCO·Brand: SUHRADAM ORTHO
Registration details
- UID
- MFG/MD/2022/000634_7f7e6aefdb08e44a88c70decf2b1de8d_e8958e340ce10193aae44edd58d66069
- Device class
- Class C
- Brand name
- SUHRADAM ORTHO
- License holder
- SUHRADAM ORTHO
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- Intended Use: SUHRADAM ORTHO’s polyaxial screw and rod system are intended for providing segmental stabilization of the spine in skeletally mature patients. Anterior Cervical Plate and Screw, The monoaxial screws and hook system are intended for use a posterior pedicle screw fixation system or posterior hook fixation system or as an anterolateral fixation system. These devices are intended for all the below: Degenerative Disc Disease, Spondylolisthesis, trauma, deformities or curvatures, stenosis, pseudoarthrosis and failed previous fusion Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy Monoaxial Screws and Hooks with spinal rods:. Rods are used in spinal surgery.
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BONE SCREW
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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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Products from the same license holder (5 products)
BONE SCREW
Brand: SUHRADAM ORTHO
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
Brand: SUHRADAM ORTHO
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Wire & Pins
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Bone Plate
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External Fixator
Brand: SUHRADAM ORTHO
Class C
About this record
Spine Implant is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2022/000634_7f7e6aefdb08e44a88c70decf2b1de8d_e8958e340ce10193aae44edd58d66069. 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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