MediSei, NeckTune™ 3D SA Cervical Cage Obtains FDA Certification in the United States

MediSei (200580) announced on June 16 that its NeckTune™ 3D SA Cervical Cage received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This one-piece spinal implant is used in anterior cervical interbody fusion procedures and can be additionally secured using screws without requiring a separate anterior plate. By employing 3D printing technology to create a porous surface, the implant allows patient bone cells to grow into the implant, creating an osteoconductive environment. Unlike traditional methods, it eliminates the need for an additional metal plate, reducing surgical steps and minimizing tissue irritation during anterior dissection. The FDA clearance strengthens MediSei's competitive position in the U.S. spinal implant market, supporting product portfolio diversification and revenue growth. As of June 16, 2026, MediSei's stock price remained at ₩11,960. The company, listed on the KOSDAQ market since October 14, 2003, is a medical device manufacturer.