# FDA 483 - Synergy Spine Solutions, Inc. - November 24, 2025

Source: https://www.keypedia.com/records/483/synergy-spine-solutions-inc/ebaf0dfe-8937-4c73-b290-54d435b68b35

> FDA 483 for Synergy Spine Solutions, Inc. on November 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Synergy Spine Solutions, Inc.
- Inspection Date: 2025-11-24
- Product Type: device
- Office Name: Denver District Office
- Summary: Synergy Spine Solutions, Inc. was inspected regarding a pivotal trial for the Synergy Disc and received a Form 483 with three observations. The inspection revealed significant issues including enrollment of ineligible subjects without proper pregnancy testing, widespread failures in protocol management and reporting to IRBs and FDA, and inaccurate or incomplete study records. These findings indicate a serious lack of oversight and compliance in the conduct of the investigational device study.

## Related Officers

- [Theressa B. Smith](https://www.keypedia.com/people/theressa-b-smith/80f0c339-7eac-4c73-b9f6-ecb368738fe6)

Company: https://www.keypedia.com/companies/synergy-spine-solutions-inc/03b624ab-f7a3-4f51-9dab-523953917173

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face