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When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Interpore Cross International ICI Occipito-Cervico-Thoracic (OCT) Rod and Plate System is indicated for:

• . DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
• Spondylolisthesis .
• . Spinal stenosis
• . Fracture/dislocation
• Atlantoaxial fracture with instability ●
• . Occipitocervical dislocation
• . Revision of previous cervical spine surgery
• Tumors

The occipital bone screws are limited to occipital fixation only.

The Interpore Cross International ICI Occipito-Cervico-Thoracic (OCT) Rod and Plate System is a titanium system composed of rods, bone screws, hooks, set screws, nuts, cross connectors, and plates. For occipito-cervico-thoracic fusion, the occipital plate is fixed to the occiput with bone screws. The pre-bent rod is cut to the appropriate length. Bone screws are placed in the thoracic spine (T1-T3) and hooks are placed in the cervical spine. The rod is inserted and the construct is locked with screws and nuts. Cross connectors can be added to the construct.

The provided text is a 510(k) summary for a medical device (Interpore Cross International (ICI) Occipito-Cervico-Thoracic (OCT) Rod and Plate System). However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

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