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

Spinal Tech

The Food and Drug Administration granted 15 spine-related device clearances in May.

1. XCage Interbody Fusion System from Ouroboros Medical.

 

2. Integra Expandable Intervertebral Body Fusion Device System from SeaSpine.

 

3. NuVasive EMG Endotracheal Tube from NuVasive.

 

4. Swift-Lock Anchor from St. Jude Medical.

 

5. InFill Cervical from Pinnacle Spine Group.

 

6. True Spinal Fusion System from Innovative Surgical Designs.

 

7. Stalif C from Centinel Spine.

 

8. SpineFrontier RedFuse Pedicle Screw System from SpineFrontier.

 

9. Neoplate Spine Anterior Fixation System from Neoortho Products Orthopedics.

 

10. NuVasive NVM5 System from NuVasive.

 

11. Romeo Posterior Osteosynthesis System from Spineart.

 

12. Trinica Anterior Lumbar Plate System from Zimmer Spine.

 

13. Everest Spinal System from K2M.

 

14. Navigated CD Horizon Solera Screwdriver/TAPS from Medtronic Sofamor Danek USA.

 

15. PEEK Cage for the Vertebral Spine from Neoortho Produtos Ortopedicos.

 

More Articles on FDA Clearances:
25 Spine Devices Receives FDA 510(k) Clearance in April
20 Spine Devices Receive FDA 510(k) Clearance in March
11 Spine Devices Receive FDA 510(k) Clearance in February

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