19 Spine Devices Receive FDA 510(k) Clearance in JanuaryWritten by Laura Miller | February 14, 2012
The Food and Drug Administration granted 19 spine-related device clearances in January, according to an FDA report.
1. Focus MIS System from L&K Biomed Co.
2. Stryker Universal Neuro 3 System from Stryker.
3. Aleutian System from K2M.
4. DSS Stabilization System from Paradigm Spine.
5. Caspian from K2M.
6. Pyrenees Cervical Plate System from K2M.
7. PEEK Prevail Cervical Interbody Device from Medtronic Sofamor Danek.
8. Leucadia Autolok Pedicle Screw System from Phygen.
9. Nanovis Spinal System from Nanovis.
10. Oasys Spinal System from Stryker Spine.
11. Reliance Spinal Screw System from Reliance Medical Systems.
12. Lexus Anterior Cervical Plate System from L&K Biomed.
13. OptiCage Interbody Fusion Device from Interventional Spine.
14. Xenon Pedicle Screw System from Alphatec Spine.
15. Cardiff Anterior Cervical Plate System from SeaSpine.
16. Spineology PEEK Bullet Lumbar Interbody Device from Spineology.
17. Pioneer Release Laminoplasty Plating System from Pioneer Surgical Technology.
18. Giza Vertebral Body Replacement from Eden Spine.
19. Santorini Spinal System from K2M.
Related Articles on Spine Devices:
26 Spine Devices Receive FDA 510(k) Clearance in December
21 Spine Devices Receive FDA 510(k) Clearance in November
21 Spine Devices Receive FDA 510(k) Clearance in October
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