42 orthopedic, spine devices receive FDA 510(k) clearance in April 2017

Spinal Tech

The FDA granted 42 orthopedic and spine related clearances in April.


1. Nile Proximal Fixation Spinal System from K2M.
2. GMK UNI from Medacta International.
3. Ortho System from 3Shape A/S.
4. Pantheon Medical Balanced Plating System from Pantheon Medical.
5. Zavation IBF from Zavation.
6. Ax Stand-Alone ALIF System from Innovasis.
7. X01 Knee Balancing System from XPandOrtho.
8. Titan 3-D Wedge System from Paragon 28.
9. MiCATM Screw System from Wright Medical Technology.
10. ExactechGPS Total Shoulder Application, Equinoxe Planning Software from Blue Ortho.
11. Exactech Alteon HA Femoral Stem from Exactech.
12. Precice Unyte CoCr System from NuVasive Specialized Orthopedics.
13. Mazor X from Mazor Robotics.
14. Leva Anterior Expandable Spacer System from Spine Wave.
15. Endoskeleton TAS Interbody Fusion Device/Hyperlordic Interbody Fusion Device from Titan Spine.
16. OsteoMed ExtrmiFix Mid and Large Screw System from OsteoMed.
17. Apex Revision Knee System from Omnilife Science.
18. Anthem Fracture System from Globus Medical.
19. SurgTech Thoracolumbosacral Posterior Fixation System from SurgTech.
20. Greens Brand Locking Bone Plates and Screw Osteosynthesis Plating System from Greens Surgicals.
21. Navigated Elevate Inserter, Navigated Disc Prep Instruments from Medtronic Sofamor Danek USA.
22. Ortholoc 3Di Ankle Fusion Plating System Line Extension from Wright Medical Technology.
23. Hoffman LRF System from Stryker GmbH.
24. Capri Corpectomy Cage System from K2M.
25. Additive Orthopaedics Locking Lattice Plate from Additive Orthopaedics.
26. Threshold Pedicular Fixation System from Spineology.
27. Threshold V2 Pedicular Fixation System from Spineology.
28. Palisade Pedicular Fixation System from Spineology.
29. Fortress Pedicular Fixation System from Spineology.
30. Smith & Nephew Sureshot Distal Targeting System V4.0 from Smith & Nephew.
31. CD Horizon Fenestrated Screw Set from Medtronic Sofamor Danek.
32. Joimax Endovapor 2 from joimax GmbH.
33. Summit Spine Yellowstone Lumbar Interbody Fusion System from Summit Spine.
34. NuVasive BASE Interfixated Titanium System from NuVasive.
35. Mako Total Hip Application from Mako Surgical.
36. Interbody Fusion/Vertebral Body Replacement System from RTI Surgical.
37. EVOS Small Fragment Plating System from Smith & Nephew.
38. HV Screw System from Wright Medical Technology.
39. The Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw Systems from Choice Spine.
40. Tomcat Cervical Spinal System from Choice Spine.
41. Zenius Spinal System from Medyssey USA.
42. Exactech Truliant Line Extensions from Exactech.


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