15 Spine Devices Receive FDA 510(k) Clearance in May

The Food and Drug Administration issued 15 spine-related 510(k) clearances in May, according to an FDA report.

1. Issys LP Spinal Fixation System from Custom Spine.

2. Ellipse Occipito-Cervico-Thoracic Spinal System from Globus Medical.

3. Streamline TL Spinal System from Pioneer Surgical Technologies.

4. SeaSpine Spacer System from SeaSpine.

5. Cougar LS Lateral Gave System from Johnson & Johnson.

6. Synthes Homeostatic Bone Putty from Synthes USA.

7. Zenius Spinal System from Medyssey.

8. Intercontinental Plate-Spacer from Globus Medical.

9. K2M COCR Wire from K2M.

10. TSRH Spinal System from Medtronic Sofamor Danek.

11. Synthes 3.5MM Low Profile Cortical Screw from Synthes USA.

12. Ascent Posterior Occipital Thoracic System from Orthofix.

13. Leucadia Pedicle Screw System from Phygen.

14. Tiger Spine System from CoreLink.

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

Related Articles on FDA Clearances:
13 Spine Devices Receive FDA 510(k) Clearances in April
22 Spine Devices Receive FDA 510(k) Clearance in March
23 Spine Devices Receive FDA 510(k) Clearance in February