Here are six spine devices and technologies earning FDA nods since Oct. 1.
1. Sync-AR earned FDA clearance for SyncAR Spine, a platform that combines XR tools and AI algorithms to support surgeons.
2. Centinel Spine received FDA premarket approval Oct. 14 for two-level use of its prodisc C Vivo and prodisc C SK cervical disc replacement devices.
3. Tenon Medical’s SImmetry+ sacroiliac joint fusion system earned the FDA’s 510(k) clearance.
4. Elevation Spine’s Saber-C earned FDA clearance for two-level cervical spinal fusion.
5. Astura Medical earned FDA 510(k) clearance for the Masada Sacral-Alar-Iliac system.
6. Augurex’s Spinestat diagnostic test earned the FDA’s breakthrough device designation.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
