by: TigerPosted on:

Spinal Device 510k Clearances in May = 20

The FDA granted 20 spine-related device clearances in May.

  1. Ayers Rock Cervical Cage from Qualgenix.
  2. Lateral Fusion Device from Integra Spine.
  3. Mont Blanc Pedicle Screw Systems from Qualgenix.
  4. Viper System from DePuy Spine.
  5. Pioneer Lateral Plate System from Pioneer Surgical.
  6. Reliance Cervical IBF System from Reliance Medical.
  7. Plateau Spacer System from Life Spine.
  8. DSS Stabilization System-Rigid from Paradigm Spine.
  9. Synster Pedicle Screw System from BM Korea.
  10. Synthes USS Connector from Synthes Spine.
  11. S 100 Pedicle Screw from Renovis Surgical Technologies.
  12. Synthes Matrix System from Synthes Spine.
  13. Range Spinal System from K2M.
  14. Tempus Cervical Plate System from Neurostructuers.
  15. Lexus Cervical Fixation System from L&K Biomed.
  16. Synthes ACIS/Vertebral Spacer from Synthes.
  17. Range Spinal System, Unit Rod from K2M.
  18. SI-FIX Sacroiliac Joint Fusion System from Medtronic Sofamor Danek.
  19. Artisan Space Maintenance System from Medtronic Sofamor Danek.
  20. Stainless Steel Spinal System from Theken Spine.