48 orthopedic devices receive FDA 510(k) clearance in June

Written by Laura Dyrda | July 07, 2017 | Print  |

The Food and Drug Administration granted 48 orthopedic- and spine-device related clearances in June.


1. DePuy Synthes 4.0 mm and 5.0 mm Locking Screws from DePuy Synthes.


2. Syntec Humeral Nail System from Syntec Scientific.


3. Sagico IBF System – Aria Lumbar, Sagico IBF System – Arion Cervical from Spinal Analytics & Geometrical.


4. Smith & Nephew R3 Constrained Liner from Smith & Nephew.


5. 2-Piece Hammertoe Correction System from Life Spine.


6. iTotal Hip Replacement System from ConforMIS.


7. Corin MetaFix Hip Stem form Corin USA.


8. Spira Open Matrix ALIF from Camber Spine Technologies.


9. Invisiknot Ankle Syndesmosis Repair Kit from Smith & Nephew.


10. PHA S1 Spinal System from Phamedica.


11. Terrace Anterior Cervical Plate System from CoreLink.


12. UTF Stem, reduced from United Orthopedic Corporation.


13. Summit Spine Channel Cervical Interbody Fusion System from Summit Spine.


14. Coalesce Lumber from Interbody Fusion System.


15. Responsive Orthopedics Total Hip Arthroplasty System from Responsive Orthopedics.


16. Additive Orthopaedics Bunion System from Additive Orthopaedics.


17. Swedge Pedicle Screw Fixation System from Spinal Resources.


18. Precice Intramedullary Limb Lengthening System from NuVasive Specialized Orthopedics.


19. BodyTom Elite from NeuroLogica Corp.


20. Gravity Syndesmosis from Wright Medical Technology.


21. Tranquil Interbody System from Nexus Spine.


22. Talos Lumbar PEEK IBF Devices from Meditech Spine.


23. Stryker SonicPin System from Stryker Trauma.


24. Procotyl Prime Acetabular Cup System from MicroPort Orthopedics.


25. Evos Small Fragment Lower Extremity Plates from Smith & Nephew.


26. SeaSpine Shoreline Anterior Cervical Standalone System from SeaSpine Orthopedics.


27. Flower Bone Screw Set from Flower Orthopedics.


28. Phantom Small Bone Intramedullary Nail System from Paragon.


29. Ashcom Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System from Zimmer.


30. VariAx 2 Compression Plating System from Stryker.


31. JAZZ System from Implanet.


32. Attune Cemented Tibial Base, Fixed Bearing from DePuy.


33. ChoiceSpine Proliant Posterior Pedicel Screw and Hook Fixation System from ChoiceSpine.


34. Unison-C Anterior Cervical Fixation System from Pioneer Surgical Technology.


35. Telix K Interbody System from Biedermann Motech.


36. Materialise Glenoid Positioning System from Materialise.


37. Complex Wireless USA from DJO.


38. Complex Sport Elite from DJO.


39. NuVasive CoRoent Small Interlock II System from NuVasive.


40. NuVasive CoRoent Thoracolumbar System from NuVasive.


41. OrthoButton from Riverpoint Medical.


42. Trifore Cervical Plating System from NeuroStructures.


43. Palisade Pedicular Fixation System from Spineology.


44. FUSE Spinal System from Medtronic Sofamor Danek.


45. Iliad Pedicle Screw System from Zenius Pedicle Screw System from Medyssey.


46. Cure Lumbar Plate System from Meditech Spine.


47. Distal Elbow Plating System from Skeletal Dynamics.


48. AOS Anterolateral Proximal Humeral Plate from Advanced Orthopaedic Solutions.


More articles on FDA clearances:
48 orthopedic devices receive FDA 510(k)clearance in May 2017
42 orthopedic devices receive FDA 510(k) clearance in April
47 orthopedic devices receive FDA 510(k) clearances in March


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