Fracture Fixation Devices - India CDSCO Medical Device Registration
Fracture Fixation Devices is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000076_5f17b74b7ff72d33dbedac3dfca57b39_545ad5e8a6c45bf9c668944c72ce91b1. This device is marketed under the brand name Cannulated Screws. The license holder is Smith & Nephew Healthcare Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Cannulated Screws
License Holder
Smith & Nephew Healthcare Pvt. Ltd.Device Class
Approving Authority
CDSCO
Product Information
"Bone plates and screws from the Smith & Nephew Bone Plate System are used for adult and pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneus; hip arthrodesis, and provisional hole fixation. The 4.0mm Cannulated Screws and associated washers are additionally intended for arthrodesis and osteotomies of small bones and small joints, including scaphoid and other carpal bones, metacarpals, tarsals, metatarsals, patella, ulnar styloid, capitellum, radial head and radial styloid. The 5.5mm, 6.5mm, 7.0mm, and 8.0mm Cannulated Screws and associated washers are additionally intended for reconstruction, osteotomy, and arthrodesis of various bones and bone fragments appropriate for the size of the device including "
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