Wire, Surgical(Atlas cable System ) - India CDSCO Medical Device Registration
Wire, Surgical(Atlas cable System ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000037_f8648c82bb117d48ef6dd264c39a461e_1e0c1213dafc5448ca1e636802a85a25. This device is marketed under the brand name CD HORIZON SOLERA Spinal System. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.
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Brand Name
CD HORIZON SOLERA Spinal System
License Holder
India Medtronic Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
Properly used, this device will aid in the repair or attachment of bony structures. The indications and contraindications of this system should be well understood by the surgeon. The system is indicated for use whenever a conservative or a non-implant surgery is deemed insuf๏ฌcient to improve the medical condition of the patient. The ATLASTM Cable System can be utilized anywhere mono๏ฌlament wire has been previously found to be indicated. The indications are: 1. Spinal applications would include sublaminar and intraspinous process wiring for trauma applications. Another application would be the use of the ATLASTM Cable System for instrumentation involved in the correction of scoliotic, kyphotic, and lordotic deformities. The stainless steel system may also be used with other stainless steel spinal implants such as the Unit Rod or Luque Rod or wherever โwiringโ may help secure the attachment of other implants. The titanium system may also be used with other titanium implants. 2. Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty. 3. Sternotomy indications would include the โre-wiringโ of osteomizing sternums. 4. Trauma surgery indications would include olecranon, ankle, patella, and some shoulder fracture rewiring
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