CDSCO UID IMP/MD/2018/000446_a0bb229365d943b819cc5e9885b35593_14792d26483409ef9a4c8fd6fbae861f
Orthosis Cervical Pedicle Screw Spinal Fixation(INFINITY™ Occipito cervical-Upper Thoracic System )
India Medtronic Private Limited·Device Class Class C·India CDSCO·Brand: Capstone Spinal System
Registration details
- UID
- IMP/MD/2018/000446_a0bb229365d943b819cc5e9885b35593_14792d26483409ef9a4c8fd6fbae861f
- Device class
- Class C
- Brand name
- Capstone Spinal System
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- The INFINITY™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (Capstone Spinal System), and the thoracic spine from T1-T3: ▪ Traumatic spinal fractures and/or traumatic dislocations. ▪ Instability or deformity. ▪ Failed previous fusions (Capstone Spinal System). ▪ Tumors involving the cervical spine. ▪ Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The INFINITY™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. In order to achieve additional levels of fixation, the INFINITY™ OCT System may be connected to the CD HORIZON™ Spinal System and VERTEX™ Reconstruction System rods with the INFINITY™ OCT System rod connectors. Transition rods with differing diameters may also be used to connect the INFINITY™ OCT System to the CD HORIZON™ Spinal System. Refer to the CD HORIZON™ Spinal System package insert and VERTEX™ Reconstruction System package insert for a list of the indications of use. Note: The 3.0mm multi axial screw (Capstone Spinal System) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is intended to be used. The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws. Note: Segmental fixation is recommended for these constructs
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About this record
Orthosis Cervical Pedicle Screw Spinal Fixation(INFINITY™ Occipito cervical-Upper Thoracic System ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000446_a0bb229365d943b819cc5e9885b35593_14792d26483409ef9a4c8fd6fbae861f. This device is marketed under the brand name Capstone 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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