Custom Spine, based in Parsippany, N.J., has recorded a pair of notable achievements—ISO-13485 certification and CE Mark from the European Union for all its current products sold in the United States.
The approval allows the company to sell its products into the international market.
Mahmoud Abdelgany, president of Custom Spine said: "We are excited to receive CE clearance and to take the next steps into distributing our products in the international arena. 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 U.S."
Custom Spine's product portfolio includes its flagship pedicle screw system, ISSYS LP. According to the company, the design of ISSYS LP allows the surgeon to fully seat the screw against bone providing 63 percent greater shear force resistance than traditional unseated screws, while maintaining full polyaxial motion of the screw head. Also included in the product portfolio is Pathway AVID, an articulating vertebral interbody device. The implant is inserted in a traditional transforaminal approach in its straight, non-articulated position. Once placed in the disc space, the implant is articulated using the specially designed inserter to create a large footprint device that follows the natural periphery of the vertebra, increasing stability and support to reduce the risk of subsidence.
Regent ACP, Custom Spine's low-profile anterior cervical plate system, also will be available in the international market and features innovative self-locking slides that allow a variety of constructs to be created while providing the surgeon with confidence that the screws are fully locked in place. Additional cleared products include Pathway PLIF and TLIF and the ISSYS LP Monoaxial and Cross Connector systems that include auxiliary connectors.