44 orthopedic, spine devices receive FDA 510(k) clearance in June

Spinal Tech

The Food and Drug Administration granted 44 spine- and orthopedic-driven device clearances in June.

1. Captiva Spine SmartLOX Cervical Plate System from Captiva Spine.

 

2. AUXEIN BRAND of Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws from AUXEIN MEDICAL.

 

3. Reliance Cervical IBF System from Reliance Medical Systems.

 

4. ELEVATE Spinal System from Medtronic Sofamor Danek USA.

 

5. Avenue T TLIF Cage from LDR Spine USA.

 

6. Mini Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360 Spinal Fixation System, Title 2 Polyaxial Spinal System from Zimmer Spine.

 

7. Biomet Orthopaedic Salvage System — Proximal Femoral & Hybrid Tibial from Biomet Manufacturing.

 

8. Iliad Pedicle Screw System and Zenius Pedicle Screw System from Medyssey USA.

 

9. APTUS Wrist 2.5 System from Medartis.

 

10. Metallic Locking Bone Plate and Screw System from Changzhou Dingjian Medical.

 

11. AOS Clavicle Intramedullary Device from Advanced Orthopaedic Solutions.

 

12. Intersomatic Cervical Device — DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device — DIMEI PEEK, Intersomatic Transforaminal — TLIF PEEK from Osteomed Implantes.

 

13. STALIF C; STALIF C-Ti from Centinel Spine.

 

14. Divergence-L Anterior/Oblique Lumbar Fusion System from Medtronic Sofamor Danek USA.

 

15. Dymaxeon Spine System from Back 2 Basics Direct.

 

16. Navigated Disc Prep Instruments and Capstone Trials from Medtronic Sofamor Danek USA.

 

17. DPZ Pedicular Fixation System from Osteomed Implantes.

 

18. NuVasive CoRoent Small Interbody System from NuVasive.

 

19. ToeTac Hammertoe Fixation System from Restore Surgical.

 

20. Total Knee Arthroplasty System from Responsive Orthopedics.

 

21. Px PEEK IBF System form Innovasis.

 

22. Freedom Spinal Cord Stimulator System from Stimwave Technologies.

 

23. Ellipse and Protex CT Occipito-Cervico-Thoracic Spinal Systems from Globus Medical.

 

24. Anax OCT Spinal System from U&I Corporation.

 

24. Tritium Sternal Cable Plate System from Pioneer Surgical Technology.

 

25. Vertaplex High Viscosity Radiopaque Bone Cement from Stryker.

 

26. Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti from Centinel Spine.

 

27. uNion Cervical Plate System from ulrich medical USA.

 

28. Zimmer PSI Shoulder System from Zimmer.

 

29. OASYS System from Stryker.

 

30. Progressive Orthopaedic Total Knee System from The Progressive Orthopaedic Company.

 

31. Sure Lok Mini Posterior Cervical/Upper Thoracic System from Precision Spine.

 

32. Affixus Tibial Nailing System from Biomet.

 

33. SMV Scientific Bone Screws from SMV Scientific.

 

34. NuVasive CoRoent Thoracolumbar Implants from NuVasive.

 

35. Virage OCT Spinal Fixation System from Zimmer Spine.

 

36. CapLOX II/Tower LOX Pedicle Screw System from Captiva Spine.

 

37. Precice Intramedullary Limb Lengthening System from Ellipse Technologies.

 

38. VariAx 2 Wrist Fusion System from Stryker Trauma.

 

39. ALIF Interfixated System from NuVasive.

 

40. Mercury Spinal System from Spinal Elements.

 

41. Lineum OCT Spine System from Biomet Spine.

 

42. Arthrex FiberTak Anchors from Arthrex.

 

43. DePuy Synthes T-PAL Ti Spacer from Synthes USA Products.

 

44. Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade from Stryker.

 

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