28 spine devices receive FDA 510(k) approval in October

Spinal Tech

The Food and Drug Administration cleared 28 spine-related devices with 510(k) approval in October.

  1. Vital Spinal Fixation System from ZimVie Spine.
  2. Acro Composites Interbody System from Acro Composites.
  3. Zeus Spinal System from Shanghai Sanyou Medical Co.
  4. Pearla TL Posterior Thoracolumbar Fixation System from Spineart.
  5. Stable-L Standalone Lumbar Interbody System from Nexus Spine.
  6. Veos Spinal Fixation System from Spineway.
  7. Pro-Link & Pro-Link Ti Barbs Cervical Spacer System from Life Spine.
  8. Anax 5.5 Spinal System from Innosys.
  9. VyLink Spinal Screw System from Vy Spine.
  10. OptiMesh Multiplanar Expandable Interbody Fusion System from Spineology.
  11. Momentum Posterior Spinal Fixation System with G21 V-Steady Bone Cement from Ulrich 16. Medical USA.
  12. ClariVy Cervical IBF System from Vy Spine.
  13. SpineEOS from EOS imaging.
  14. MedactaLIF Anterior Lag Extension from Medacta International.
  15. Ascend VBR System, Ascend NanoTec VBR System from Alphatec Spine.
  16. Reunion Sacroiliac Joint Fusion System from Astura Medical.
  17. Victory Lumbar Plate System from Globus Medical.
  18. CarboClear Pedicle Screw System from Carbofix Orthopedics.
  19. Rigel 3DR Standalone Anterior Cervical Interbody Fusion System from MiRus.
  20. Vy Spine VyLam Laminoplasty System from Vy Spine.
  21. Rigel 3DR Anterior Cervical Corpectomy System from MiRus.
  22. KeyLift Expandable Interlaminar Stabilization System from FloSpine.
  23. Calibrate CCX Interbody System from Alphatec Spine.
  24. Ripley Spinal Screw System by Sagico from Sagico.
  25. Rexious Spinal Fixation System, Statera Spinal System, from K&J Consulting Corp.
  26. Peridot-TD Spacer System from GBS Commonwealth.
  27. PressON Spinal Fixation System from Nexus Spine.
  28. Solace Sacroiliac Fixation System from Xenix Medical.

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