39 orthopedic, spine devices receive FDA 510(k) clearance in August

Written by Laura Dyrda | September 08, 2014 | Print  |

 The Food and Drug Administration granted 39 orthopedic- and spine-related device clearances in August.

 1. Kiva VCF Treatment System from Benvenue Medical.

 

2. OrthoHub External Fixator Software from OrthoHub.

 

3. DePuy Synthes Tomofix Osteotomy System from Synthes USA.

 

4. BioLox Delta Ceramic Option Heads from Biomet.

 

5. Arthrex Ankle Fusion Plating System from Arthrex.

 

6. Zimmer Plates and Screws System – Non-Sterile Plates and Screws from Zimmer.

 

7. InFront Lumbar Interbody Fusion System from InFront.

 

8. Confirm Bioactive from Globus Medical.

 

9. Exactech Cervical Spacer System from Exactech.

 

10. iKnee Distal Femoral Cutting Guide from Evergreen Orthopedic Research Lab.

 

11. CD Horizon Spinal System from Medtronic Sofamor Danek.

 

12. PerFuse Percutaneous Decompression System from Biomet.

 

13. Stryker Universal Orbital Floor System from Stryker.

 

14. Evolution MP CS/CR Porous Femor/Evolution Adaptive CS and PS Inserts from MicroPort Orthopedics.

 

15. Variax 2 System from Stryker Trauma.

 

16. Romeo PAD Posterior Axial Device from Spineart.

 

17. Isola and Expedium Growing Spine Systems from Medos SARL.

 

18. Valor Hindfoot Fusion Nail System from Wright Medical Technology.

 

19. Stryker Steri-Shield Flyte Hybrid Togas from Stryker.

 

20. OrthoHelix Staple System from OrthoHelix Surgical Designs.

 

21. VertiForm Posterior Fixation System from Next OrthoSurgical.

 

22. Intraosseous Fixation System from OrthoHelix.

 

23. VAPR Arctic Suction Electrode from DePuy Mitek.

 

24. Integra Mozaik Osteoconductive Scaffold – Strip from Integra LifeSciences.

 

25. Z-Link Cervical from Zavation.

 

26. Arthrex Fibertak Suture Anchor from Arthrex.

 

27. Mercury Spinal System from Spinal Elements.

 

28. Distal Elbow Plating System from Skeletal Dynamics.

 

29. Zimmer Periarticular Locking System form Zimmer.

 

30. Alteon Neck Preserving Femoral Stem from Exactech.

 

31. AAP Loqtec Cervical Plates from aap Implantate.

 

32. Aequalis Reversed Shoulder Prosthesis from Tornier.

 

33. Total Shield Surgical from Zimmer.

 

34. Lateral VBR System from NuVasive.

 

35. MUST Pedicle Screw System from Medacta.

 

36. Reduce Fracture Plating System Line Extension from Icon Orthopedic Concepts.

 

37. Triathlon Knee System Posterior Stabilization Components from Stryker Orthopaedics.

 

38. Skaffold NMX Bone Void Filler from Skeletal Kinetics.

 

39. Thunderbolt and Lancer Pedicle Screw Systems from Choice Spine.

 

More articles on FDA clearances:
52 spine, orthopedic devices receive FDA 510(k) clearance in July
35 spine, orthopedic devices receive FDA 510(k) clearance in June
39 spine, orthopedic devices receive FDA 510(k) clearance in May

 

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies here.

Top 40 Articles from the Past 6 Months