Here are eight spine medtech products earning FDA approvals and clearances in the third quarter of 2023:
1. Icotec's Vader pedicle system navigated instruments earned FDA 510(k) clearance. The navigation set includes instruments for open and minimally invasive spine surgery.
2. Curiteva received FDA 510(k) approval for its pedicle and sacroiliac joint navigation instruments.
3. ZimVie earned FDA approval for its new version of the Mobi-C cervical disc.
4. Wenzel Spine earned FDA clearance for the PrimaLOK SP system. The device is designed for spinal fusion and can be used at multiple levels for patients with lumbar spinal stenosis.
5. OnPoint Surgical earned the FDA's 510(k) clearance for its OnPoint Augmented Reality Spine System.
6. Medical Metrics' Spine Camp platform earned FDA 510(k) clearance.
7. ChoiceSpine recently received FDA clearance to market its Blackhawk Ti 3D-printed cervical spacer system.
8. Spine devicemaker 4Web Medical earned FDA 510(k) clearance to market the Cervical Spine Truss System Integrated Plating Solution.