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The NuVasive® AP Expandable XLIF System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion. The AP Expandable XLIF System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the AP Expandable XLIF System. The AP Expandable XLIF System is intended to be used with supplemental internal spinal fixation systems (e.g., pedicle screw/ rod systems) that are cleared by the FDA for use in the lumbar spine.

The NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The System is designed for use with autogenous bone graft to facilitate fusion. The MLX – Medial Lateral Expandable Lumbar Interbody System is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the MLX - Medial Lateral Expandable Lumbar Interbody System. The MLX -Medial Lateral Expandable Lumbar Interbody System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

The NuVasive Sterile MLX and APX Interbody Devices are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and ISO 5832-3, Ti-6AI-4V conforming to ASTM 1472, Nitinol SE508 conforming to ASTM F2063, and Nickel-Cobalt-Chromium-Molybdenum alloy (MP35N) conforming to ASTM F562. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers addition of sterile packaged implants to previously cleared systems.

This document is about the FDA 510(k) clearance of the NuVasive® MLX™ - Medial Lateral Expandable Lumbar Interbody System and NuVasive® AP Expandable XLIF System. It does not describe an AI medical device or a study proving its performance. Thus, I cannot provide the requested information.

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