EXALTA Group, a next-generation partner to MedTech innovators, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Anterior Cervical Plating (ACP) System, designed to support stability and fusion in the cervical spine.
MARQUETTE, MI, UNITED STATES, November 13, 2025 EXALTA Group, a next-generation partner to MedTech innovators, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Anterior Cervical Plating (ACP) System, designed to support stability and fusion in the cervical spine.
The ACP system is indicated for anterior fixation of the cervical spine (C2–C7) as an adjunct to fusion in skeletally mature patients. The titanium plates incorporate an integrated active locking mechanism and are available in multiple lengths to accommodate both constrained and variable screws.
“Our goal was to engineer a plating system that delivers strong fixation, intuitive handling, and surgical flexibility,” said Jason Sandstrom, VP of R&D at EXALTA. “The design reflects deep collaboration with surgeons and a thorough evaluation of clinical requirements. The integrated locking mechanism simplifies intraoperative workflow while ensuring screw security, and the variable screw angulation supports anatomical precision, even in complex revision cases. Paired with optimized plate contours and a balanced screw diameter range, the system is built for consistent clinical performance.”
This latest clearance further expands EXALTA’s portfolio of FDA-cleared platforms, which now includes more than 150 FDA 510(k) approvals. Combined with EXALTA’s multi-continent manufacturing network, OEM partners gain access to scalable production aligned with global market needs.
Built for speed, EXALTA helps MedTech innovators accelerate launches and strengthen market positions while keeping internal teams focused on what matters most: core IP and clinical excellence.
“Each clearance strengthens our mission to empower customers with turnkey, validated systems that move seamlessly from concept to commercialization,” said Ross Sylvia, Chief Commercial Officer, Integrated OEM Solutions at EXALTA. “It’s a great example of how EXALTA challenges the status quo – refining established platforms and bridging the gap between design, clinical application, and scalable production to advance MedTech innovation.”
EXALTA will showcase the recently cleared Anterior Cervical Plating System at the North American Spine Society (NASS) Annual Meeting, taking place November 14-16 in Denver, CO (Booth #1335). OEMs interested in exploring private-label opportunities are invited to connect with our teams.
Learn more at www.exalta.com