39 Orthopedic & Spine Devices Receives FDA 510(k) Clearance in November

1. Nano Suture Anchor from Linatec Corporation.

2. Leucadia MIS Pedicle Screw System from Phygen.

3. Aequalis Shoulder System from Tornier

4. Ascension NuGrip CMC Implant from Ascension Orthopedic.

5. Trimed Clavicle Fixation System from Trimed.

6. Milestone Knee System from TGM Medical.

7. Synthes Zero-P Variable Angle from Synthes Spine.

8. Prow Fusion from NLT Spine.

9. Calix PC Spinal Implant System from X-Spine Systems.

10. Nanovis Intervertebral Body Fusion System from Nanovis.

11. Telamon PEEK Spinal System from Medtronic Sofamor Danek.

12. Humelock Cemented Shoulder Prosthesis from FX Solutions.

13. Knotless Suture Fixation System from Core Essence Orthopaedics.

14. Intramedullary Internal Fixation Nail from Vilex.

15. Acu-Sinch Repair System and Acumed Suture Anchor from Acumed.

16. Peri-loc Proximal Femur Locking Bone Plates from Smith & Nephew.

17. Acufex Director Application Anatomic Guide System from Smith & Nephew Endoscopy.

18. RSP Glenoid Baseplate Porus Coated from Encore Medical.

19. Sterispineps Pedicle Screw from Safe Orthopaedics.

20. Anatomic PEEK Cervical Fusion System from Medtronic Sofamor Danek.

21. Synthes SynPOR HD Porous Polyethylene Three Dimensional Implants from Synthes.

22. Synthes LCP Pedintric Plate Systems from Synthes.

23. Memometal Intramedullary Bone Fastener from Memometal Technologies.

24. Guardian Inflatable Bone Expander System from BM Korea.

25. Synthes USS Connectors from Synthes Spine.

26. PASS LP Spinal System from Medicrea International.

27. S4 Spinal System from Aesculap Implant System.

28. Gibralt Spine Systems Facet Screw from Exactech.

29. CD Horizon Spinal System from Medtronic Sofamor Danek USA.

30. Clydesdales Spinal System from Medtronic Sofamor Danek USA.

31. DePuy Pulse Anterior Cervical Plate System from Medos Interational Sarl.

32. Devine Spinal System from Changzhou Orthmed Medical Instruments.

33. NB3D Bone Void Filler from Pioneer Surgical Technology.

34. Zavation Spinal System from Zavation.

35. Trabecular Metal Fusion Device from Zimmer Spine.

36. Profemur Gladiator HA Hip Stem from Wright Medical Technology.

37. Raptor Facet Fixation System from Alphatec Spine.

38. Synthes Brainlab Trauma Compatible Instruments from Synthes Products.

39. Rhausler Plage Anterior Cervical Fusion System from Rhausler.


Josh Sandberg

Josh Sandberg is the President of Ortho Spine Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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