Matrix Surgical has obtained CE mark and ISO 13485:2003 certification for its OMNIPORE High-density Porous Polyethylene craniofacial implants.
The craniofacial implants, which are manufactured in the US, are designed for use in reconstructive and aesthetic craniofacial surgeries.
Matrix Surgical sales executive vice president Alvaro Rodriguez said, "Achieving ISO certification, combined with our CE Mark, opens the door for worldwide distribution of our products."
Matrix Surgical president and CEO John O’Shaughnessy said the company can now provide surgeons in all countries recognizing the CE mark with OmniPore surgical implants.
"These state-of-the-art sterile devices are of the highest quality and provide a cost-effective solution to the difficult challenges faced by craniofacial surgeons every day," O’Shaughnessy added.
In addition, the company has filed a 510(k) application, for seeking approval from the US Food and Drug Administration for its OmniPore implants.