The Food and Drug Administration issued 13 spine-related device clearances in March.
1. TM Ardis Interbody System Inserter from Zimmer Trabecular Metal Technology.
2. Solus Anterior Lumbar Interbody Fusion System from Alphatec Spine.
3. Nautilus Spinal System from Life Spine.
4. Grafton II from Medtronic Sofamor Danek.
5. GSO GS1 Cannulated Screw System from Gold Standard Orthopaedics.
6. Silex Sacroiliac Joint Fusion System from X-Spine Systems.
7. S4 Spinal System from Aesculap Implant Systems.
8. Ellipse Occipito-Cervico-Thoracic Spinal System and Capitol Implants from Globus Medical.
9. Lanx Fusion System from Lanx.
10. Pass OCT Spinal System from Medicrea Interventional.
11. Spineology PEEK Lumbar Interbody Fusion Device from Spineology.
12. Anatomic PEEK Cervical Fusion System Cornerstone from Medtronic Sofamor Danek.
13. Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps from Medtronic Navigation.
More Articles on Device Clearances:
22 Spine Devices Receive FDA 510(k) Clearance in February
11 Spine Devices Receive FDA 510(k) Clearance in January
21 Spine Devices Receive FDA 510(k) Clearance in December
1. TM Ardis Interbody System Inserter from Zimmer Trabecular Metal Technology.
2. Solus Anterior Lumbar Interbody Fusion System from Alphatec Spine.
3. Nautilus Spinal System from Life Spine.
4. Grafton II from Medtronic Sofamor Danek.
5. GSO GS1 Cannulated Screw System from Gold Standard Orthopaedics.
6. Silex Sacroiliac Joint Fusion System from X-Spine Systems.
7. S4 Spinal System from Aesculap Implant Systems.
8. Ellipse Occipito-Cervico-Thoracic Spinal System and Capitol Implants from Globus Medical.
9. Lanx Fusion System from Lanx.
10. Pass OCT Spinal System from Medicrea Interventional.
11. Spineology PEEK Lumbar Interbody Fusion Device from Spineology.
12. Anatomic PEEK Cervical Fusion System Cornerstone from Medtronic Sofamor Danek.
13. Navigated CD Horizon Solera Screwdrivers, Taps, Iliac Taps, Legacy Taps from Medtronic Navigation.
More Articles on Device Clearances:
22 Spine Devices Receive FDA 510(k) Clearance in February
11 Spine Devices Receive FDA 510(k) Clearance in January
21 Spine Devices Receive FDA 510(k) Clearance in December