20 Spine Devices Receive FDA 510(k) Clearance in August

Spinal Tech

Surgical GloveThe Food and Drug Administration granted 20 spine-related device clearances in August.

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1. Firebird Spinal Fixation System from Orthofix.
2. Expandable Lumbar Interbody System from NuVasive.
3. PediGuard Nerve Detector System from SpineGuard.
4. Osseus Black Diamond Pedicle Screw System from Osseus Fusion Systems.
5. CD Horizon Spinal System from Medtronic Sofamor Danek USA.
6. Caplox II Pedicle Screw System/Towerlox Pedicle Screw System from Captiva Spine.
7. Facet Screw System from Spinal USA.
8. Surfix Interspinous Fusion System from JG Spine.
9. Capsure PS System from Spine Wave.
10. Core Pedicle Screw System from Core-Nexus.
11. C-Fuse Cervical Intervertebral Body Fusion System from Southern Spine.
12. Irix-C Cervical Integrated Fusion System from X-Spine Systems.
13. Kinex Bioactive from Globus Medical.
14. Staxx IBL System from Spine Wave.
15. Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation from Accel Spine.
16. Pagoda Pedicle Screw System from Ortho Development.
17. Mountaineer Oct. Spinal Surface from Medos International SARL.
18. ArthroCare Coblator IQ DLR Spinewand from ArthroCare.
19. Tempus Cervical Plate System from NeuroStructures.
20. Lliad, Kora, Zenius Pedicle Screw System from Medyssey USA.

 

More Articles on Spine Clearances:
12 Spine Devices Receive FDA 510(k) Clearance in July
11 Spine Devices Receive FDA 510(k) Clearance in June

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