Corporate Compliance

Centinel Spine, LLC desires to ensure that its operations continue to be conducted in accordance with all national, state and local laws and regulations. To underscore and enhance our commitment to ethical behavior in all that we do, we have implemented a Corporate Compliance Program. Our Corporate Compliance Program is intended to establish a framework for legal compliance by the company and our personnel.

We strive to provide surgeons with the products, services and information they need to provide the best for their patients. We have established a reputation of trust that must be preserved and strengthened. We are committed to fostering an environment that encourages all Centinel Spine, LLC. personnel to actively participate in accomplishing effective compliance with all laws and regulations. We are proud to demonstrate our commitment to following all legal requirements and ethical principles in providing our products and services.

Centinel Spine, LLC has been, and continues to be, committed to conducting its business in full compliance with all national, state and local laws and regulations. We are particularly committed to preventing, detecting and resolving non-compliance with these requirements. The Corporate Compliance Program aids Centinel Spine in this prevention, detection and resolution. We require that all compliance issues encountered be raised, thoroughly investigated and resolved in a timely manner in accordance with this Compliance Program. The Compliance Program is designed to assist Centinel Spine in protecting the excellent reputation and high levels of trust that we have established in the market.

Please contact our Compliance Officer, Jeffrey Miller at JBM@granitegrcconsulting.com or (717) 556-1088 or the Centinel Spine compliance hotline at (866) 460-9408 with any questions or concerns.

For more information, see the AdvaMed Code of Ethics.

The Sunshine Act

Centinel Spine, LLC has an obligation to collect and report payments and transfers of value made to physicians in accordance with the provisions of the Physician Payment Sunshine Act beginning August 1, 2013. Transfers of value related to events will be recorded and reported accordingly.

California Certification

Declaration of Adoption of Comprehensive Compliance Program Pursuant to California Health and Safety Code Section 119400-119402

Centinel Spine designs, manufactures and sells orthopedic medical devices. As a medical device manufacturer with a strong commitment to ethical behavior, Centinel Spine has adopted a Comprehensive Compliance Program in accordance with the Compliance Program Guidance developed by the United States Department of Health and Human Services Office of Inspector General.

This Comprehensive Compliance Program includes written standards, employee training, an anonymous hotline, monitoring, a Code of Business Conduct, dedicated compliance office leadership and other elements of an effective program. As an organization we strive to conduct all of our business interactions with healthcare professionals in a compliant and ethical manner.

Our Code of Conduct sets out the expectation of behavior expected of all employees and specific sections of the Code of Conduct summarize Centinel Spine policies regarding interactions with medical or health care professionals.

Centinel Spine has adopted a Compliance Policy for interactions with health care professionals which is based on the Advanced Medical Technology Association Code of Ethics on Interactions with Health Care Professionals (the “AdvaMed Code”; effective July 1, 2009), and which regulates the Company’s interactions with health care professionals. Centinel Spine has supplemented the AdvaMed Code with certain provisions necessary to comply with state laws governing these interactions as appropriate.

Our policies on interacting with Healthcare Professionals establishes explicit limits on meals, promotional materials or items or activities that Centinel Spine or its representatives may give or otherwise provide to an individual medical or health care professional ($2,000 per surgeon annual limit).

To the best of our knowledge, Centinel Spine is in all material respects in compliance with a Comprehensive Compliance Program (“CCP”) that satisfies the requirements of California Health and Safety Code §§ 119400-119402, based on our good faith understanding of the statutory provisions as they may apply to a medical device manufacturer.

Questions on the Code of Conduct, our Comprehensive Compliance Program, requests for materials or any addition questions can be directed to our Compliance Officer at (717) 556-1088.  –  Updated as of August 31, 2020.