Company Compliance
How We Operate
Surgeons, physicians, and patients trust us with decisions that matter. This page explains the standards we hold ourselves to, how we enforce them, and how to reach us.
Our Compliance Standards, In Plain Language
Amplio Spine is committed to operating with integrity in every aspect of how we develop, manufacture, market, and sell our medical devices. Our compliance program is built on the U.S. Department of Health and Office of Inspector General (OIG) General Compliance Program Guidance (GCPG) (November 2023) and the AdvaMed Code of Ethics on Interactions with Health Care Professionals.
We have chosen to adopt and publish this program because it is the right way to run a medical device company. Amplio Spine’s decision to publish this program and the accompanying annual declaration is voluntary.
01
We follow the law
Federal, state, and FDA rules are not preferences — the Anti-Kickback Statute, the False Claims Act, and the Sunshine Act are the floor we work from.
02
We protect the patient
Every decision is filtered through one question: would this hold up to scrutiny if a patient were watching? If not, we don’t do it.
03
We act on what we find
When we discover a problem, we investigate, discipline, and disclose. No quiet warnings. No second chances on the things that matter.
Our Standard for Accountability
A compliance page on a website is a low bar — anyone can post one. The point of this one is that we mean what it says. We expect every employee, officer, director, contractor, and anyone acting on Amplio Spine’s behalf to know our internal policies, follow them, and ask before they act when they are unsure. Surgeons, physicians, hospitals, and the patients on the table are counting on us getting that right.
When we become aware of potential violations, we investigate. Where a violation is confirmed, we discipline up to and including termination, pursue civil action where appropriate, and refer matters for criminal prosecution where warranted. We do not issue warnings for serious violations. We update this program as the business, the law, and best practices evolve.
Our Compliance Framework
The seven elements of our program track the OIG framework, in plain English:
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Written rules
Internal policies that govern how we sell, market, and interact with the healthcare community.
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Training that happens
When you join, and at least once a year after that.
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Consistent consequences
The same rules apply to every employee, regardless of title or revenue.
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Real corrective action
Prompt investigation, discipline where warranted, and fixes designed to keep the problem from happening again.
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Named owners
A designated compliance contact and Corporate Counsel, with Board oversight.
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Open lines
Multiple ways to ask questions or raise concerns, with a non-retaliation guarantee.
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Active monitoring
Periodic review of the highest-risk areas — HCP interactions, promotional activity, and clinical studies.
Disclosure and Conflicts
We disclose. Authors, contributors, and editors associated with any journal, society, or organization publishing materials about Amplio Spine or its products are required to disclose their relationship with the Company. Investigators and others involved in our research are obligated to disclose their relationships with us to patients, employers, journals, societies, institutions, and the public where required or appropriate.
Where required by law, the Company reports payments and transfers of value to covered recipients — including physicians and teaching hospitals — under the federal Physician Payments Sunshine Act.
2026 Annual Declaration
To the best of its knowledge, Amplio Spine is, in all material respects, in compliance with the program described on this page and with the federal and state laws that govern the marketing and sale of its products. We expect to issue a similar declaration on or about each anniversary of the effective date below.
Amplio Spine
Effective: June 16, 2026
AM01-0058