Spinal implant specialist Custom Spine Inc has announced that it has achieved ISO-13485 and received CE Mark for all its current products sold in the U.S. This approval allows the Company to commercialize its products into the international market.
ISSYS LP is Custom Spine’s flagship pedicle screw system which allows the surgeon to fully seat the screw against bone providing 63% greater shear force resistance than traditional unseated screws, while maintaining full polyaxial motion of the screw head.
Pathway AVID (video here) , a unique 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, will also 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 which include auxiliary connectors.
Mahmoud Abdelgany, President of Custom Spine commented, “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.”
Source: Custom Spine Inc