The Food and Drug Administration issued 23 spine-related 510(k) clearances in February, according to an FDA report.
1. Polaris Spinal System from Biomet Spine.
2. Talon Spinal System from Spine 360.
3. InterFuse DA Interbody Fusion System from Vertebral Technology.
4. Golden Gate Anterior Plate System from Ulrich GMBH & Co.
5. Cohesion Bone Cement form Teknimed.
6. CoRoent Interlock System from NuVasive.
7. Vitoss BA Boost Bioactive Bone Graft Substitute from Orthovita.
8. Leucadia Pedicle Screw System from Phygen.
9. Lanx Posterior Cervicothoracic Spinal Fixation System from Lanx.
10. Fuse PLIF Café from Advanced Medical Technologies.
11. Venus Basic Spinal Fixation System from L&K Biomed.
12. Venus Anterior Cervical Plate from Verticor.
13. Lanx Fusion System from Lanx.
14. 4CIS Vane Spine System from Solco Biomedical.
15. Bright Spine Galileo Spinal Spacer System from Bright Spine.
16. Skyline Anterior Cervical Plate System from Johnson & Johnson.
17. PSL Anterior Cervical Plate System from Precision Surgery.
18. ArthroCare Parallax Contour Vertebral Augmentation Device from ArthroCare.
19. Spartek Variable Angle Pedicle Screw Posterior Fusion System from Spartek Medical.
20. Expedium Spine System, Moss Miami Spine System from Johnson & Johnson.
21. Synthes Scout Vessel Guard from Synthes Spine.
22. Kyphon Xpede Bone Cement from Medtronic.
23. Lanx Cervical Intervertebral Body Fusion System from Lanx.
Read the full FDA coverage of the medical devices cleared in February by the FDA.
Read other coverage on spine device clearances:
- 18 Spine Devices Receive FDA 510Kk) Clearance in January
- 15 Spine Devices Receive FDA 510(k) Clearance in December
1. Polaris Spinal System from Biomet Spine.
2. Talon Spinal System from Spine 360.
3. InterFuse DA Interbody Fusion System from Vertebral Technology.
4. Golden Gate Anterior Plate System from Ulrich GMBH & Co.
5. Cohesion Bone Cement form Teknimed.
6. CoRoent Interlock System from NuVasive.
7. Vitoss BA Boost Bioactive Bone Graft Substitute from Orthovita.
8. Leucadia Pedicle Screw System from Phygen.
9. Lanx Posterior Cervicothoracic Spinal Fixation System from Lanx.
10. Fuse PLIF Café from Advanced Medical Technologies.
11. Venus Basic Spinal Fixation System from L&K Biomed.
12. Venus Anterior Cervical Plate from Verticor.
13. Lanx Fusion System from Lanx.
14. 4CIS Vane Spine System from Solco Biomedical.
15. Bright Spine Galileo Spinal Spacer System from Bright Spine.
16. Skyline Anterior Cervical Plate System from Johnson & Johnson.
17. PSL Anterior Cervical Plate System from Precision Surgery.
18. ArthroCare Parallax Contour Vertebral Augmentation Device from ArthroCare.
19. Spartek Variable Angle Pedicle Screw Posterior Fusion System from Spartek Medical.
20. Expedium Spine System, Moss Miami Spine System from Johnson & Johnson.
21. Synthes Scout Vessel Guard from Synthes Spine.
22. Kyphon Xpede Bone Cement from Medtronic.
23. Lanx Cervical Intervertebral Body Fusion System from Lanx.
Read the full FDA coverage of the medical devices cleared in February by the FDA.
Read other coverage on spine device clearances:
- 18 Spine Devices Receive FDA 510Kk) Clearance in January
- 15 Spine Devices Receive FDA 510(k) Clearance in December