The Food and Drug Administration granted 21 spine-related device clearances in December.
1. Polaris Spinal System—Ballista II Rods from Biomet Spine.
2. Firebird Spinal Fixation System from Orthofix.
3. Phoenix MIS Spinal Fixation System from Orthofix.
4. Galleon Pedicle Screw Systems from Everest Spine.
5. LessRay from SafeRay Spine.
6. IN:C2 Spinal Fixation System from Spine Smith Partners.
7. Patriot Spacers from Globus Medical.
8. ES2 Spinal System from Stryker Spine.
9. V2F Anterior Fixation System from Zimmer Spine.
10. NuVasive Bendini Spinal Rod Bending System from NuVasive.
11. Malibu Spinal System With the Daytona Deformity System from SeaSpine.
12. S4 Spinal System from Aesculap Implant Systems.
13. Ascendx VCF Reduction System from AIO Medical.
14. Anodyne Anterior Cervical Plate System from CoreLink.
15. VertiFlex Spinous Process Fixation Plate from VertiFlex.
16. Synthes Navigable Pedicle Preparation Instruments from Synthes Spine.
17. Stablink MIS Spinal Fixation System from Southern Spine.
18. Kyphon Express II Inflatable Bone Tamps from Medtronic.
19. A-Wedge Anterior Interbody System from Sapphire Medical Group.
20. Flexlite Camera from Spine View.
21. DePuy Pulse Anterior Cervical In-Line Plate System from Medos International.
More Articles on Spine Device Clearances:
16 Spine Devices Receive FDA 510(k) Clearance in November
24 Spine Devices Receive FDA 510(k) Clearance in October
13 Spine Devices Receive FDA 510(k) Clearance in September
1. Polaris Spinal System—Ballista II Rods from Biomet Spine.
2. Firebird Spinal Fixation System from Orthofix.
3. Phoenix MIS Spinal Fixation System from Orthofix.
4. Galleon Pedicle Screw Systems from Everest Spine.
5. LessRay from SafeRay Spine.
6. IN:C2 Spinal Fixation System from Spine Smith Partners.
7. Patriot Spacers from Globus Medical.
8. ES2 Spinal System from Stryker Spine.
9. V2F Anterior Fixation System from Zimmer Spine.
10. NuVasive Bendini Spinal Rod Bending System from NuVasive.
11. Malibu Spinal System With the Daytona Deformity System from SeaSpine.
12. S4 Spinal System from Aesculap Implant Systems.
13. Ascendx VCF Reduction System from AIO Medical.
14. Anodyne Anterior Cervical Plate System from CoreLink.
15. VertiFlex Spinous Process Fixation Plate from VertiFlex.
16. Synthes Navigable Pedicle Preparation Instruments from Synthes Spine.
17. Stablink MIS Spinal Fixation System from Southern Spine.
18. Kyphon Express II Inflatable Bone Tamps from Medtronic.
19. A-Wedge Anterior Interbody System from Sapphire Medical Group.
20. Flexlite Camera from Spine View.
21. DePuy Pulse Anterior Cervical In-Line Plate System from Medos International.
More Articles on Spine Device Clearances:
16 Spine Devices Receive FDA 510(k) Clearance in November
24 Spine Devices Receive FDA 510(k) Clearance in October
13 Spine Devices Receive FDA 510(k) Clearance in September