70 spine devices that received FDA 510(k) approval since the pandemic began

Laura Dyrda -   Print  |

Here are the spine devices that have received FDA 510(k) clearance since March.

March

1. Megafix Pedicle Screw Spinal System from SeohanCare.
2. Capstone Spinal System, Clydesdale PTC Spinal System, Crescent Spinal System from Medtronic Sofamor Danek.
3. Icotec Cervical Cage from icotec.
4. Mecta-C Stand Alone from Medacta.
5. Response Spine System from OrthoPediatrics.
6. Nano FortiFix System from Nanovis Spine.
7. CarboClear Lumbar Cage System from CarboFix Orthopedics.
8. SeaSpine Skipjack System from SeaSpine Orthopedics.
9. Tritium Sternal Cable Plate System from Pioneer Surgical Technology.
10. SI-Bone iFuse Implant System from SI-Bone.
11. NuVasive Cohere Thoracolumbar Interbody System from NuVasive.
12. NuVasive 3DP Interfixated ALIF System from NuVasive.
13. NorthStar OCT Spinal System from SeaSpine Orthopedics.
14. MectaLIF Anterior Simple from Medacta International.
15. Response BandLoc Spinal Fixation from OrthoPediatrics.
16. SEA-LINK Anterior Cervical Plate System from Indius Medical Technologies.
17. LOSPA IS Spinal Fixation System from Corentec.
18. The Gecko Spinal System from Ortho Development Corporation.
19. Nexxt Matrixx Stand Alone Cervical-Turn Lock System from Nexxt Spine.

April

20. Comet Lumbar Interbody Fusion Cage from Baui Biotech.
21. Sirion Lateral Lumber Interbody System from Astura Medical.
22. Verticale Cervical System from Silony Medical.
23. Galileo Vertebral Body Replacement Device from Bright Spine.
24. El Captain Anterior Lumber Interbody System from Astura Medical.
25. Symphony OCT System from Medos International.
26. Spira-C Integrated Fixation System from Camber Spine Technologies.
27. Origin Anterior Cervical Plate System from Orthopaedic & Spine Development.
28. SeaSpine Reef TH System from SeaSpine Orthopedics.
29. ARx Spinal System from Life Spine.
30. ProLift Lateral Fixated from Life Spine.
31. Biolign Roto-Loc Cervical Plate System from Elite Surgical Supplies.
32. Hive Stand-alone Anterior Lumbar Interbody System from HD LifeSciences.
33. EVOS Lumbar Interbody System from Cutting Edge Spine.
34. Tritanium X TL Expandable Curve Posterior Lumbar Cage from Stryker.
35. Stryker Xia 3 Power Adaptor from Stryker Spine.
36. Firebird SI Fusion System from Orthofix.
37. HydroCision SpineJet System from HydroCision.
38. SpineEx Sagittae Lateral Lumber Interbody Fusion Devices from SpineEX.
39. Tiger Occipital-Cervical-Thoracic Spinal Fixation System from CoreLink.
40. SI-Restore Sacroiliac Joint Fusion System from Biofusion Medical.
41. Solstice CCI from Life Spine.

May

42. MiRus 3d Printed Lumbar Interbody Fusion Systems from MiRus.
43. Precice Bone Transport System from NuVasive Specialized Orthopedics.
44. VADERone Pedicle System MIS and LIghtMore Pedicle System 6.0 form Icotec.
45. Audere Lumbar Spacer System from Met One Technologies.
46. Precice Screws from NuVasive Specialized Orthopedics.
47. Anterior Spine Truss System – Stand Alone Interbody Fusion Device from 4Web.
48. Reform Pedicle Screw System from Precision Spine.
49. Axis Spine Technologies ALIF from Axis Spine Technologies.
50. ROSA ONE Brain application form Medtech.
51. PERLA Posterior Occipito-Cervico-Thoracic Fixation System from Spineart.
52. Meridian Anterior Plate System, Regatta Lateral Plate System from SeaSpine Orthopedics.
53. Mazor X from Mazor Robotics.
54. Invictus CT Spinal Fixation System from Alphatec Spine.
55. NuVasive Thoracolumbar Plates from NuVasive.
56. Nexxt Matrixx System from Nexxt Spine.
57. EVOL Spinal Interbody System from Cutting Edge Spine.
58. Insignia Anterior Cervical Plate System from Alphatec Spine.
59. NuVasive ACP System from NuVasive.
60. Cure Lumbar Plate System from Meditech Spine.

June

61. Spinal Fixation System from Shangdon Kangsheng Medical Device.
62. SpineFrontier Lumbar Interbody Fusion Device System from SpineFrontier.
63. F3D Cervical Stand-Alone Interbody Fusion System from CoreLink.
64. Medussa-PL Cage from Medyssey USA.
65. IlluminOss Bone Stabilization System from IlluminOss Medical.
66. Altus Spine Pedicle Screw System from Altus Partners.
67. Rigel 3DR Anterior Cervical Interbody Fusion System from MiRus.
68. SeaSpine Meridian System, SeaSpine Regatta Lateral System from SeaSpine Orthopedics.
69. Sapphire Spinal System, Sapphire X Anterior Cervical Plate Spinal System from Spinal Elements.
70. Centurion POCT System from Orthofix.

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