1. Reliance Spinal Screw System from Reliance Medical Systems.
2. Life Spine Interspinous Fixation System from Life Spine.
3. Appliance, Fixation, Spinal Invertebral Body from Alphatec Spine.
4. Endoskeleton TO from Titan Spine.
5. Modification to Oasys System from Stryker Spine.
6. Modification to Lanx Posterior Cervicothoracic Spinal Fixation System from Lanx.
7. Viper F2 Facet Fixation System from DePuy Spine.
8. Choice Spine Starfire Pedicle Screw System from Choice Spine.
9. CD Horizon Spinal System from Medtronic Sofamor Danek.
10. MOUNTAINEER Oct Spinal System from DePuy Spine.
11. Axle Interspinous Fusion System from X-Spine Systems.
12. Staxx XD System from Spine Wave.
Read the FDA release on November 510(k) clearances.
Read other coverage on orthopedic and spine device clearances:
– 35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in November
– 16 Spine Devices Receive FDA 510(k) Clearances in October
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.
