Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc

Post Approval Study Protocol for the Two Level Simplify® Cervical Artificial Disc

This study is intended to demonstrate the 5-year long-term safety and efficacy of the Simplify® Cervical Artificial Disc ("Simplify Disc") in subjects enrolled in the non-randomized two-level Simplify Disc Investigational Device Exemption (IDE) study. This study was conducted under IDE G150206

Inclusion Criteria:

- All subjects enrolled in the two level Simplify Disc IDE study are considered for this long-term follow-up study.

Exclusion Criteria:

• Subjects who were not implanted with the Simplify Disc during the IDE study
• Subjects who had a secondary surgical intervention at the index level during the IDE study
• Subjects who were withdrawn or withdrew consent to participate in the IDE study
• Subjects who do not consent to participate in long-term follow-up post-approval study