External Fixation System-Wires
- UID
- IMP/MD/2018/000076_abf4222d5e0f03ca39f37009afe65677_7c3e922d7a74460305f3120ac06b0d30
- Device class
- Class C
- Brand name
- JOURNEY
- License holder
- Smith & Nephew Healthcare Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- The wires and pins are the implantable components used in external fixation devices whose indications for use are: 1. Post-Traumatic joint contracture which has resulted in loss of range of motion (JOURNEY) 2. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction 3. Open and closed fracture fixation 4. Pseudoarthrosis of long bones 5. Limb lengthening by epiphyseal or metaphyseal distraction (JOURNEY) 6. Correction of bony or soft tissue deformities (JOURNEY) 7. Correction of segmental bony or soft tissue defects 8. Joint arthrodesis (JOURNEY) 9. Infected fractures or nonunions 10. Mini external fixator systems are indicated for the management of comminuted intraarticular fractures of the distal radius (JOURNEY) 11. Calandruccio devices are indicated for arthrodesis of the ankle or subtalar joints, as well as some select fractures, nonunion, or osteotomy of the distal tibia; and acute transverse fractures or nonunion of the distal tibia (JOURNEY)
External Fixation System-Wires is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000076_abf4222d5e0f03ca39f37009afe65677_7c3e922d7a74460305f3120ac06b0d30. This device is marketed under the brand name JOURNEY. The license holder is Smith & Nephew Healthcare Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.
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