CDSCO UID MFG/MD/2021/000156_704d6652e7ac5c17ab95e50e3793ee7e_b556b5f0383ff21b5c179bf908b72812

BONE NAILS

Orthoflex Medisys India Pvt Ltd·Device Class Class C·India CDSCO·Brand: ORTHOFLEX MEDISYS INDIA PVT. LTD.

Registration details

UID: MFG/MD/2021/000156_704d6652e7ac5c17ab95e50e3793ee7e_b556b5f0383ff21b5c179bf908b72812
Device class: Class C
Brand name: ORTHOFLEX MEDISYS INDIA PVT. LTD.
License holder: Orthoflex Medisys India Pvt Ltd
Approving authority: Central Drug Standards Control Organization, Ahmedabad
Product information: Interlocking nails include severely comminuted, spiral, large oblique and segmental fractures; nonunion and mal-unions; and bone lengthening/shortening. Femoral interlocking nails include the indication for proximal, middle and distal third femoral shaft fractures. Tibial interlocking nails also include the same indications for tibial shaft fractures. Humeral interlocking nails are indicated for humeral shaft fractures, including severely comminuted, spiral, large oblique and segmental fractures; nonunion and mal-unions, proximal, middle and distal third shaft fractures; polytrauma and/or multiple fractures; humerus reconstruction, following tumor resection and grafting; and prophylactic nailing of impending pathologic fractures. R/U Interlocking nails are indicated for radial and ulnar shaft fractures, including severely comminuted, spiral, large oblique and segmental fractures; nonunion and malunion; proximal middle and distal third shaft fractures; polytrauma and/or multiple fractures. Interlocking reconstruction nails are indicated for the following: Subtrochanteric fractures with lesser Trochanteric involvement; ipsilateral femoral shaft/neck fractures; severely comminuted shaft fractures; femur reconstruction following tumor resection and grafting; bone shortening/lengthening; and prophylactic nailing of impending pathologic fractures. Retrograde nails are indicated for shaft fractures including severely comminuted, spiral, large oblique and segmental fractures; nonunion and malunion; bone lengthening/shortening; femur reconstruction Following tumor resection and grafting; fractures in osteoporotic bone; severely comminuted shaft fractures; pathologic fractures, pseudoarthrosis, failed osteosynthesis; closed Supracondylar fractures; and prophylactic nailing of impending pathologic fractures. Additional indications for retrograde nails include: severely comminuted Supracondylar fractures with or without difficult intra-articular extension, fractures that require opening the knee joint to stabilize the femoral condylar segment. K-Nail is indicated for Tibia, Femur and Humreus shaft fracture. Gam Nail is indicated for Subtrochanteric Fracture. Elastic Nail (ORTHOFLEX MEDISYS INDIA PVT. LTD.) is indicated for Humerus and Tibia and Femur Fracture. Ender's Nail is indicated for Humerus and Tibia and Femur Fracture. Ankle Arthodesis Nail is indicated for Foot and ankle Fracture. DIMSC Locked Nail is indicated for Supracondylar Fracture. Interlocking Nail Cap, Nail Plug Safety Star drive (ORTHOFLEX MEDISYS INDIA PVT. LTD.), Interlocking Guide Wire-Simple and Interlocking Guide Wire-Olive Tip (ORTHOFLEX MEDISYS INDIA PVT. LTD.) are indicated for Nail and Bone Fixation