40 Orthopedic & Spine FDA 510(k) Device Clearances in July
Food and Drug Administration granted 40 orthopedic- and spine-related device clearances in July. 1. Spinal Elements Cerclage System from Spinal Elements.
2. Spine Frontier Indus ACP System from Spine Frontier.
3. Fortify Integrated Corpectomy Spacers from Globus Medical.
4. DePuy Pulse Lumbar Cage System from Medos International Sarl.
5. CD Horizon Spinal System from Medtronic Sofamor Danek.
6. Aequalis Adjustable Modular Reverse Shoulder System from Tornier.
7. Synthes 2.7/3.5 MM Variable Angle LCP Ankle Trauma System-Anteriolateral Distal Tibia Plate from Synthes.
8. Venus Lumbar Intervertebral Body Fusion Cage System from L&K Biomed.
9. Seviin Reverse Shoulder from Ingen Orthopedics.
10. Arrow Reverse Shoulder System from Fournitures Hopitalieres Industry.
12. Smarttitch M-Connector Ultra SmartStitch Suture Device from ArthroCare.
13. Renaissance from Mazor.
14. InFill Intervertebral Body Fusion Device from Pinnacle Spine Group.
15. NuVasive Brigade Anterior Plate System from NuVasive.
16. U2 Acetabular Cup, Plasma Spray from United Orthopedic.
17. Pathfinder NXT Minimally Invasive Pedicle Screw System from Zimmer Spine.
18. M.U.S.T. Pedicle Screw System from Medacta International.
19. MEDIACREA International Anterior Lumbar Plate from MEDICREA International.
20 3.9MM Reflix STT Suture Anchor System from Stryker.
21. 10 Fix, 10 Fix Plus, CarpalFix, Extremity Medical Screw & Washer from Extremity Medical.
22. XMCP, Hallux, Tasrx, Extremity Medical Screw System from Extremity Medical.
23. SL-Plus Standard and Lateral Femoral Stem With TI/HA Coating from Smith & Nephew.
24. Orthofix ACP Anterior Cervical Plate System from Orthofix.
25. Caspian 3.5/4.5 Connectors from K2M.
26. HLS UNI Evolution & U-KneeTec from Tornier.
27. Hoffman 3 Modular External Fixation System from Stryker.
28. Synthes Zero-P Veriable Angle from Synthes Spine.
29. LDR Spine USA Avenue L Interbody Fusion from LDR Spine.
30. Pioneer Sternal Assist Implant System from Pioneer Surgical.
31. Comprehensive Reverse Shoulder from Biomet.
32. Stryker All Suture Anchors from Stryker.
33. Beacon Stabilization System from Globus Medical.
34. Sovereign Spinal System from Medtronic Sofamor Danek.
35. Vega Knee System from Aesculap Implant Systems.
36. Matisse Anterior Cervical Interbody Fusion Cage System from Accel Spine.
37. Spinal Elements Posterior Cervical/Thoracic Spinal System from Spinal Elements.
38. Sterispineps Pedicle Screw, Rod from Safe Orthopaedics.
39. Hip Systems from Homedica Osteonics.
40. Synthes Matrix System from Synthes Spine.
More Articles on Orthopedic Devices:
41 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in June
43 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in May
33 Orthopedic & Spine Devices Receive FDA 510(k) Clearance
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