The Food and Drug Administration granted 11 spine-related device 510(k) clearances in September, according to an FDA report.
1. Pilot Spinal System from Life Spine.
2. A-Wedge Anterior Interbody System from SpineWorks.
3. Endoskeleton TAS from Titan Spine.
4. Discovery from Intuitive Spine.
5. Medical Concepts Interbody Fusion System from Medical Concepts.
6. Captiva Spine CapLx II Spinal Fixation System from QualiReg Resources.
7. CD Horizon Spinal System from Medtronic Sofamor Danek.
8. Sure Lok Mini Posterior Cervical/Upper Thoracic System from Spinal USA.
9. Odalys Pedicle Screw System from Kalitec Direct.
10. Pass LP Spinal System from Medicrae International.
11. Spineology PEEK Bullet Lumbar Interbody Fusion Device from Spineology.
Related Articles on Spine Device Clearances:
19 Spine Devices Receive FDA Clearance in August
20 Spine Devices Receive FDA 510(k) Clearance in July
12 Spine Devices Receive FDA 510(k) Clearance in June
2. A-Wedge Anterior Interbody System from SpineWorks.
3. Endoskeleton TAS from Titan Spine.
4. Discovery from Intuitive Spine.
5. Medical Concepts Interbody Fusion System from Medical Concepts.
6. Captiva Spine CapLx II Spinal Fixation System from QualiReg Resources.
7. CD Horizon Spinal System from Medtronic Sofamor Danek.
8. Sure Lok Mini Posterior Cervical/Upper Thoracic System from Spinal USA.
9. Odalys Pedicle Screw System from Kalitec Direct.
10. Pass LP Spinal System from Medicrae International.
11. Spineology PEEK Bullet Lumbar Interbody Fusion Device from Spineology.
Related Articles on Spine Device Clearances:
19 Spine Devices Receive FDA Clearance in August
20 Spine Devices Receive FDA 510(k) Clearance in July
12 Spine Devices Receive FDA 510(k) Clearance in June