The Food and Drug Administration granted 19 spine-related medical device approvals in September.
1. VariLIFT-L Interbody Fusion Device from Wenzel Spine.
2. Ardis Interbody System from Zimmer Spine.
3. Interfuse L Intervertebral Body Fusion Device from Vertebral Technologies.
4. Spinal Intervertebral Body Fixation Orthosis from Accel Spine.
5. Integra Interspinous Process System from SeaSpine.
6. Polaris Spinal System from Biomet Spine.
7. Sequoia Pedicle Screw System Including SpeedLink II Traverse Connector System from Zimmer Spine.
8. Tiger Spine System from CoreLink.
9. Expedium Viper, Viper 2 Spine System from DePuy Spine.
10. AccuLIF and PL Cage from Coalign Innovations.
11. Rampart-O, Rampart-T from Spineology.
12. Opticage Interbody Fusion Device from Interventional Spine.
13. Lospa IS Pedicle Screw from Corentec.
14. Coroent Single Tab System from NuVasive.
15. Reliance Cervical IBF System from Reliance Medical Systems.
16. Anatomic PEEK Cervical Fusion System from Medtronic Sofamor Danek.
17. T2 XVBR Spinal System from Medtronic Sofamor Danek.
18. Perimeter Interbody Fusion Device from Medtronic Sofamor Danek.
19. Tyber Medical Interbody System ACIF, ALIF, PLIF, TLIF, DLIF from Tyber Medical.
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11 Spine Devices Receive FDA 510(k) Clearance in June