Custom Spine announced in a press release that it has achieved ISO-13485 and received a CE mark for all of its products currently sold in the United States. This will allow the company to commercialize its products in the international market, according to a press release.
Included in Custom Spine’s product portfolio are the ISSYS LP, a pedicle screw system, and the Pathway AVID, an articulating vertebral interbody device.
“We are excited to receive CE clearance and to take the next steps into distributing our products in the international arena,” Mahmoud Abdelgany, president of Custom Spine, stated in the release. “This is a significant milestone for Custom Spine, and we are looking forward to working with our international partners in offering our products outside of the US.”