CDSCO UID IMP/MD/2018/000446_c862db7ad8a5a765d5d5b83e43145fc9_c4c5676e152be6edf0d02891dfbeedd6
Spinal Interlaminal Fixation Orthosis
India Medtronic Private Limited·Device Class Class C·India CDSCO·Brand: Capstone Spinal System
Registration details
- UID
- IMP/MD/2018/000446_c862db7ad8a5a765d5d5b83e43145fc9_c4c5676e152be6edf0d02891dfbeedd6
- Device class
- Class C
- Brand name
- Capstone Spinal System
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine (Capstone Spinal System), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following: DDD (Capstone Spinal System), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, and/or tumors. Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine. Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs. Hooks and Rods The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (Capstone Spinal System) spine. Multi-axial Screws The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine. Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine. Connectors In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use
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About this record
Spinal Interlaminal Fixation Orthosis is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000446_c862db7ad8a5a765d5d5b83e43145fc9_c4c5676e152be6edf0d02891dfbeedd6. 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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