From navigation platforms to implants, here is the spine technology earning FDA clearances since July 8.
1. Providence Medical Technology earned FDA clearance for its Corus posterior cervical stabilization to treat up to three-level cervical degenerative disc disease.
2. Stryker's Q Guidance System with Spine Guidance 5 Software featuring Copilot earned 510(k) clearance from the FDA.
3. Camber Spine earned FDA 510(k) approval for its Spira-A integrated fixation system. The device is designed for anterior lumbar interbody fusion and allows packing with bone graft material.
4. Life Spine earned clearance from the FDA to market its ARx SAI spinal fixation system. The fixation system can be utilized through a sacral alar Iliac trajectory in S1 and/or S2, providing maximum fixation across the sacroiliac joint.
5. DePuy Synthes, Johnson & Johnson's orthopedic company, earned FDA 510(k) clearance for and launched Velys Spine. Velys Spine is a dual-use robotics and standalone navigation platform designed to plan and instrument spinal fusions.
6. SI-Bone earned FDA 510(k) clearance and breakthrough device designation for the iFuse Torq TNT implant system. The implants are designed for pelvic fragility fracture fixation and sacroiliac joint fusion.