Aziyo Biologics, Inc.

Aziyo Biologics, Inc. specializes in absorbable surgical envelopes designed for various medical procedures. These include standard, extra-large, and subcutaneous (SubQ) versions, as well as neuro-specific variants tailored for neurological applications. Additionally, the company produces the VasCure device for carotid artery repair and the ProxiCor device for pericardial closure, both intended for vascular and cardiac surgical interventions.

Aziyo Biologics, Inc. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.

Aziyo Biologics, Inc.’s devices are listed in the EU’s eudamed database and the FDA’s 510(k) registry. These registries track medical devices that have undergone regulatory review processes, such as the FDA’s 510(k) premarket notification or EU conformity assessment procedures.

Aziyo Biologics, Inc.’s devices fall into two regulatory classes: Class II and Class III. Class II devices generally pose moderate risk and require special controls to ensure safety and effectiveness, while Class III devices are higher risk and typically require premarket approval due to insufficient data from general controls alone. The classification depends on the device’s intended use and potential risk to patients.