40 orthopedic devices receive FDA 510(k) clearance in April

Spinal Tech

The FDA cleared 40 orthopedic devices in April 2020.

1. The Optimotion Blue Total Knee System from Optimotion Implants.

2. Comet Lumbar Interbody Fusion Cage from Baui Biotech.

3. Atlas Plating System from MiRus.

4. Sirion Lateral Lumber Interbody System from Astura Medical.

5. Verticale Cervical System from Silony Medical.

6. Galileo Vertebral Body Replacement Device from Bright Spine.

7. El Captain Anterior Lumber Interbody System from Astura Medical.

8. Symphony OCT System from Medos International.

9. Spira-C Integrated Fixation System from Camber Spine Technologies.

10. Comprehensive Reverse Shoulder from Biomet.

11. Humeral Cup Stability and Humeral Cup 135/145 Stability from FX Shoulder.

12. Origin Anterior Cervical Plate System from Orthopaedic & Spine Development.

13. ArthrexVIP Web Portal from Arthrex.

14. Sigma High Performance Partial Knee System from DePuy Ireland.

15. Verasense for Zimmer Biomet Persona from OrthoSensor.

16. SeaSpine Reef TH System from SeaSpine Orthopedics.

17. Profemur Gladiator Thin HA Classic Hip Stem with Collar from MicroPort Orthopedics.

18. ARx Spinal System from Life Spine.

19. Zimmer Hip Joint Replacement from Zimmer.

20. Expedium Spine System; Expedium Verse Spine System from Medos International.

21. ProLift Lateral Fixated from Life Spine.

22. Akros Suture Anchor LisFranc Repair Kit from Akros Medical.

23. Biolign Roto-Loc Cervical Plate System from Elite Surgical Supplies.

24. Hive Stand-alone Anterior Lumbar Interbody System from HD LifeSciences.

25. EVOS Lumbar Interbody System from Cutting Edge Spine.

26. Tritanium X TL Expandable Curve Posterior Lumbar Cage from Stryker.

27. OrthoAlign Plus System from OrthAlign.

28. Verasense for Stryker Triathlon from OrthoSensor.

29. Stryker Xia 3 Power Adaptor from Stryker Spine.

30. Firebird SI Fusion System from Orthofix.

31. Kyocera Bipolar Hip System from Kyocera Medical Technologies.

32. HydroCision SpineJet System from HydroCision.

33. DB-Orthopedics from Dimensional Bioceramics.

34. CoLink Cfx Plating System from In2Bones USA.

35. Affixus Natural Nail System Humeral Nail from Zimmer.

36. SpineEx Sagittae Lateral Lumber Interbody Fusion Devices from SpineEX.

37. Smith+Nephew Visionaire Patient Matched Cutting Blocks from Smith+Nephew.

38. Tiger Occipital-Cervical-Thoracic Spinal Fixation System from CoreLink.

39. SI-Restore Sacroiliac Joint Fusion System from Biofusion Medical.

40. Solstice CCI from Life Spine.

More articles on orthopedic devices:

Aetna sued for policy switch excluding customized knee implants
Zimmer Biomet posts $509M loss in Q1; expects 'significant negative impact' in Q2
Safe Orthopaedics negotiates acquisition of LCI Medical, strives for financial balance in 2022

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