MCRA, a leading independent Clinical Research Organization (CRO) specializing in medical devices, diagnostics, and biologics.
Company played a critical role in assisting Orthobond in securing a De Novo grant from the US Food and Drug Administration (FDA) for the Mariner Pedicle Screw System with Ostaguard™ coating.
This grant represents a significant milestone as it is the first spine device with a coating designed to reduce bacterial contamination in the operating room.
Orthobond engaged MCRA in March 2020 to support their pre-submission efforts and obtain FDA feedback on their proposed performance testing for the Ostaguard antibacterial technology.
MCRA’s Spine team developed the regulatory strategy, managed the pre-submission process, and supported Orthobond throughout the entire FDA procedure, ultimately submitting the De Novo request.
The FDA granted approval for the Ostaguard antibacterial coating on the SeaSpine Mariner Pedicle Screw System for commercial use on April 5th.
The De Novo grant commitment to innovation and represents a significant advancement in patient care and safety.
The FDA's favorable decision underscores Orthobond's vision and the transformative potential of Ostaguard in healthcare.
Collaborations on pioneering technologies, which assured them of MCRA’s capability to guide the De Novo process for the Ostaguard antibacterial surface technology.
Source: https://www.prnewswire.com/news-releases/mcra-partner-orthobond-granted-de-novo-for-innovative-pedicle-screw-system-with-ostaguard-coating-302137135.html
