22 spine devices receive FDA 510(k) clearance in April

Laura Dyrda -   Print  |

The FDA cleared 22 spine-related devices in April 2020.

1. Comet Lumbar Interbody Fusion Cage from Baui Biotech.
2. Sirion Lateral Lumber Interbody System from Astura Medical.
3. Verticale Cervical System from Silony Medical.
4. Galileo Vertebral Body Replacement Device from Bright Spine.
5. El Captain Anterior Lumber Interbody System from Astura Medical.
6. Symphony OCT System from Medos International.
7. Spira-C Integrated Fixation System from Camber Spine Technologies.
8. Origin Anterior Cervical Plate System from Orthopaedic & Spine Development.
9. SeaSpine Reef TH System from SeaSpine Orthopedics.
10. ARx Spinal System from Life Spine.
11. ProLift Lateral Fixated from Life Spine.
12. Biolign Roto-Loc Cervical Plate System from Elite Surgical Supplies.
13. Hive Stand-alone Anterior Lumbar Interbody System from HD LifeSciences.
14. EVOS Lumbar Interbody System from Cutting Edge Spine.
15. Tritanium X TL Expandable Curve Posterior Lumbar Cage from Stryker.
16. Stryker Xia 3 Power Adaptor from Stryker Spine.
17. Firebird SI Fusion System from Orthofix.
18. HydroCision SpineJet System from HydroCision.
19. SpineEx Sagittae Lateral Lumber Interbody Fusion Devices from SpineEX.
20. Tiger Occipital-Cervical-Thoracic Spinal Fixation System from CoreLink.
21. SI-Restore Sacroiliac Joint Fusion System from Biofusion Medical.
22. Solstice CCI from Life Spine.

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