16 Spine Devices Receive FDA 510(k) Clearances in October

The Food and Drug Administration issued 16 spine devices 510(k) clearances in October, according to an FDA report.

1. Xiphos Interbody Fusion System from DiFusion Technologies.

2. Caspian Spinal System from K2M.

3. Paradigm Interspinous Fusion Plate from Paradigm Spine.

4. Interfuse T Intervertebral Body Fusion Device from Vertebral Technologies.

5. Modification to the Expedium Spine System from DePuy Spine.

6. Small Plateau Spacer System from Life Spine.

7. Kyphon Xpander II Inflatable Bone Tamp from Medtronic.

8. Sapphire Anterior Cervical Plate System from Spinal Elements.

9. KAPSS Spinal System from Robert Reid.

10. LDR Spine USA SpineTune TL Spinal System from LDR Spine USA>

11. Viper Spine System from DePuy Spine.

12. T2 XVBR 1.2 Spinal System from Medtronic Sofamor Danek.

13. Pioneer Spinous Process Fusion Plate from Pioneer Surgical Technology.

14. Clavicle Locking Plate System from Newclip Technics.

15. Kyphon Anchor Facet Screw System from Medtronic.

16. FM-02 Bone Graft Substitute from Orthovita.

Read the full FDA report on device clearances in October.