Intramedullary Nail System - India CDSCO Medical Device Registration
Intramedullary Nail System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000242_a0470d33dd646aec07464bc35a718ee4_2dcc83442053bcb7668ae3a49a689ead. This device is marketed under the brand name TRIGEN. The license holder is Smith & Nephew Healthcare Pvt. Ltd. ,501 to 509, B Wing, Dynasty Business Park, Andheri-Kurla Road, Andheri East, Tal -Andheri East ( Mumbai-Zone 5 ) ,Mumbai City Maharashtra ,400059 ,India, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
TRIGEN
Device Class
Approving Authority
CDSCO
Product Information
Indications for interlocking intramedullary nails include simple long bone fractures; severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening. Interlocking intramedullary nails are indicated for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
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