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

Written by Laura Dyrda | July 14, 2019 | Print  |

The FDA granted clearance to 34 spine and orthopedic related devices last month.

1. AXTi Titanium Stand-Alone ALIF System from Innovasis.

2. High Tibial Osteotomy Correction System from Paonan Biotech.

3. Galileo Spine alignment Monitoring System from MiRus.

4. Oyster ACIF Cage from Silony Medical.

5. Arzzt Distal Radius and Ulna System from Truemed Group.

6. Mini Cannulated Headed and Headless Screw Set from Stryker.

7. Unity Total Knee System from Corin USA.

8. Spineart Navigation Instrument System from Spineart.

9. Lateral Plate System from CoreLink.

10. DJO Acetabular System from Encore Medical.

11. Vanguard XP Knee System from Zimmer.

12. Renovis A200 PS Knee System from Renovis Surgical Technologies.

13. Stryker Elite Attachments, Stryker Heavy Duty Attachments from Stryker.

14. SpaceFlex Knee from G21.

15. LineSider Spinal System from Integrity Implants.

16. RIVAL View Plating Systems and Reduce Fracture Plating Systems from Orthofix.

17. Aequalis Ascend Flex Shoulder System from Tornier.

18. Aequalis Flex Revive Shoulder System from Tornier.

19. Vader one Pedicle System MIS and LightMore Pedicle System 6.0 from icotec ag.

20. MicroLink All-Suture Button Fixation System from Conmed.

21. Signature ONE System from Orthosoft.

22. Rigel PEEK Anterior Cervical Interbody Fusion System from MiRus.

23. LxHA PEEK Lateral IBF System from Innovasis.

24. DePuy Synthes Plates and Screws Portfolio from DePuy Synthes.

25. The Jasper Spinal Fixation System II from GBS Communications.

26. Republic Spine Restore Cervical Interbody Fusion System from Republic Spine.

27. MedactaScrew PEEK Interference Screw from Medacta.

28. Stryker MIS and Footed Attachments from Stryker.

29. Solanas Posterior OCT Fixation System from Alphatec Spine.

30. Navio from Blue Belt Technologies.

31. Arthrex SwiveLock Suture Anchor from Arthrex.

32. Idys ALIF TiVac from Clariance.

33. Spine & Trauma Navigation from Brainlab.

34. T2 Alpha Femur Antegrade GT/PF Nailing System from Stryker Trauma.

More articles on orthopedic devices:
Medtronic, Smith & Nephew & more: 10 device company notes
8 leadership changes in spine, orthopedic device companies in June
SeaSpine launches lateral interbody fusion system

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