47 orthopedic & spine devices receive FDA 510(k) clearance in April

Spinal Tech

The Food and Drug Administration granted 47 orthopedic- and spine-related devices in April.

 

1. Interbody Cage from Eisertech.

 

2. Physica KR Knee System from Lima Corporate.

 

3. Reliance Interspinous Plate System from Reliance Medical Systems.

 

4. Solstice OCT System from Life Spine.

 

5. Zavation Posterior LEIF from ZAVATION.

 

6. G-scan Brio from Esaote.

 

 

7. Aptis Medical Distal Radio Ulnar Joint Implant from Aptis Medical.

 

8. Aptus Foot System from Medartis.

 

9. Corin TaperFit Hip System from Corin USA.

 

10. Reliance Posterior Cervical-Thoracic System from Reliance Medical Systems.

 

11. CD Horizon Spinal System, IPC Powerease System from Medtronic Sofamor Danek.

 

12. PLIF STS, TLIF STS, OLIF STS from 4Web.

 

13. Argulated Locking Plates from OsteoMed.

 

14. LnK Cervical Interbody Fusion Cage System from L&K Biomed.

 

15. Venus Spinal Fixation System from L&K Biomed.

 

16. Blueprint Patient Specific Instrumentation from Tornier.

 

17. Acumed Ankle Plating System from Acumed.

 

18. VAPR Tripolar Suction Electrode from DePuy Mitek.

 

19. NuVasive CCX-L Interbody System from NuVasive.

 

20. Equinoxe Mega Prosthesis from Exactech.

 

21. NuVasive Reline System from NuVasive.

 

22. Arthrex Blunt Tip Screws with Fiber Tape from Arthrex.

 

23. FortiBridge Anterior Cervical Plate System from Nanovis Spine.

 

24. Implanet Spine System from Implanet.

 

25. Arthrex Distal Radius System from Arthrex.

 

26. SpineFrontier SIJ Fuse Sacroiliac Joint Fusion Device System from SpineFrontier.

 

27. Profemur Preserve Size 1-3 Hip Stems from Microport Orthopedics.

 

28. SMV Scientific 4.5 mm Bone Screws from Summit Medventures.

 

29. InFill Interbody Fusion Devices from Pinnacle Spine.

 

30. Facet-Link Stabilization Platform from Facet-Link.

 

31. Solstice OCT System from Life Spine.

 

32. Streamline OCT System from Pioneer Surgical Technology.

 

 

33. Republic Spine Dark Star Spinal System from Republic Spine.

 

34. ProFemur Preserve Classic Stem from Microport Orthopedics.

 

35. 18ch T/R Knee Coil from Quality Electrodynamics.

 

36. QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve Stimulator from CyMedica Orthopedics.

 

37. Arthrex Plates, Screws and Staples from Arthrex.

 

38. Kyphon HV-R Bone Cement from Medtronic Sofamor Danek.

 

39. Zimmer Nexel Total Elbow Ulnar Cement Diverter from Zimmer.

 

40. Santis Pedicle Screw System from Lanterna Medical Technologies.

 

41. Darco Locking Bone Plate System from Wright Medical Technologies.

 

42. Aequalis PerFORM+ Shoulder System from Tornier.

 

43. Polyscrew Pedicle Screw System from New Era Orthopedics.

 

44. PRECICE Intramedullary Limb Lengthening System from Ellipse Technologies.

 

45. SI-BONE iFuse Implant System from SI-BONE.

 

46. Incite Anchored Cervical Interbody Device from Incite Innovation.

 

47. aap Cortical Screw 1.5, self-tapping from aap Implantate.

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