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The SUMMIT® SI OCT Spinal Fixation System and MOUNTAINEER® OCT Spinal System are intended to provide immobilization and stabilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3):

• · traumatic spinal fractures and/or traumatic dislocations;
• · instability or deformity;
• · failed previous fusions (e.g. pseudarthrosis);
• · tumors involving the cervical/thoracic spine;

• and degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and

· degenerative disease of the facets with instability.

The SUMMIT and MOUNTAINEER Systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The SONGER® Wire/Cable System to be used with the SUMMIT and MOUNTAINEER Systems allows for wire/cable attachment to the posterior cervical spine.

The SUMMIT and MOUNTAINEER Systems can also be linked to the ISOLA®, MONARCH®, MOSS® MIAMI, VIPER® and EXPEDIUM® Spine Systems using the dual wedding band and axial connectors, and via dual diameter rods.

The SUMMIT and MOUNTAINEER Systems are posterior spinal fixation systems intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3). The systems are composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The systems consist of bone anchors including hooks, SONGER® cables and screws, longitudinal members including rods and occipital plates, transverse connectors including cross connectors and interconnection mechanisms including lateral offset connectors, cable connectors, set screws, nuts, axial and wedding band connectors. The system components are implanted using class I exempt manual surgical instruments. This premarket notification expands the indications for use of the SUMMIT and MOUNTAINEER Systems to include posterior cervical screw fixation.

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML device performance. This document is a 510(k) premarket notification for a spinal fixation system, focusing on its substantial equivalence to predicate devices based on technological characteristics and mechanical performance testing, rather than an AI/ML driven device and its performance metrics.

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