The Food and Drug Administration granted 37 orthopedic- and spine-related device clearances in September. 1. Orthofix Galaxy Fixation System from Orthofix.
2. TENS Back Pain Relief System from Savia Limited.
3. IOI Total Hip from Iconacy Orthopedic Implants.
4. Mets Smiles Total Knee Replacement from Stanmore Implants Worldwide.
5. Reliance Anterior Cervical Plate System from Reliance Medical Systems.
6. ConforMIS iUni Unicondylar Knee Replacement System from ConforMIS.
7. DePuy CTA Reverse Shoulder System from DePuy France.
8. MaxLock Extreme System from OrthoHelix Surgical Designs.
9. Smith & Nephew Shoulder System Instruments from Smith & Nephew.
10. Unity Total Knee System from Corin USA.
11. Taperset Hip Small Stems from Consensus Orthopedics.
12. Lanx Spinal Fixation System from Lanx.
13. Range Spinal System from K2M.
14. Quintex Cervical Plating System from Aesculap Implant Systems.
15. iTotal Cruciate Retaining Knee Replacement System from ConforMIS.
16. NuVasive Precept Spinal System from NuVasive.
17. Van Gogh Anterior Cervical Plate System from Accel Spine.
18. DX-D Full Leg Full Spine from AFGA Healthcare.
19. Corin MetaFix Hip Stem from Corin USA.
20. Oxford Ankle Fusion Nail System from Ortho Solutions.
21. ZMR Hip System from Zimmer.
22. KMC Kyphoplasty System from Shanghai Kinetic Medical.
23. BioFiber Suture from Tornier.
24. OrthoCAD Software Option from Esaote.
25. Mets Modular Distal Femur from Stanmore Implants Worldwide.
26. Mets Modular Total Femur from Stanmore Implants Worldwide.
27. Mets Modular Proximal Femur from Stanmore Implants Worldwide.
28. SteriSpine LC Cage from Safe Orthopaedics.
29. Orthofix Contours Proximal Humeral Plate from Orthofix.
30. Choice Spine Fixation System from Choice Spine.
31. NextGen Altius Oct System from Biomet Spine.
32. Speedlock Hip Knotless Fixation Implant from ArthroCare.
33. Dali Spinal Fixation System from Accel Spine.
34. Arthrex Suture from Arthrex.
35. Oracle Lumbar Intervertebral Body Fusion Cage System from Accel Spine.
36. Short Superior Clavicle Plate from Advanced Orthopaedic Solutions.
More Articles on FDA Clearances:
32 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in August
40 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in July
41 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in June
2. TENS Back Pain Relief System from Savia Limited.
3. IOI Total Hip from Iconacy Orthopedic Implants.
4. Mets Smiles Total Knee Replacement from Stanmore Implants Worldwide.
5. Reliance Anterior Cervical Plate System from Reliance Medical Systems.
6. ConforMIS iUni Unicondylar Knee Replacement System from ConforMIS.
7. DePuy CTA Reverse Shoulder System from DePuy France.
8. MaxLock Extreme System from OrthoHelix Surgical Designs.
9. Smith & Nephew Shoulder System Instruments from Smith & Nephew.
10. Unity Total Knee System from Corin USA.
11. Taperset Hip Small Stems from Consensus Orthopedics.
12. Lanx Spinal Fixation System from Lanx.
13. Range Spinal System from K2M.
14. Quintex Cervical Plating System from Aesculap Implant Systems.
15. iTotal Cruciate Retaining Knee Replacement System from ConforMIS.
16. NuVasive Precept Spinal System from NuVasive.
17. Van Gogh Anterior Cervical Plate System from Accel Spine.
18. DX-D Full Leg Full Spine from AFGA Healthcare.
19. Corin MetaFix Hip Stem from Corin USA.
20. Oxford Ankle Fusion Nail System from Ortho Solutions.
21. ZMR Hip System from Zimmer.
22. KMC Kyphoplasty System from Shanghai Kinetic Medical.
23. BioFiber Suture from Tornier.
24. OrthoCAD Software Option from Esaote.
25. Mets Modular Distal Femur from Stanmore Implants Worldwide.
26. Mets Modular Total Femur from Stanmore Implants Worldwide.
27. Mets Modular Proximal Femur from Stanmore Implants Worldwide.
28. SteriSpine LC Cage from Safe Orthopaedics.
29. Orthofix Contours Proximal Humeral Plate from Orthofix.
30. Choice Spine Fixation System from Choice Spine.
31. NextGen Altius Oct System from Biomet Spine.
32. Speedlock Hip Knotless Fixation Implant from ArthroCare.
33. Dali Spinal Fixation System from Accel Spine.
34. Arthrex Suture from Arthrex.
35. Oracle Lumbar Intervertebral Body Fusion Cage System from Accel Spine.
36. Short Superior Clavicle Plate from Advanced Orthopaedic Solutions.
More Articles on FDA Clearances:
32 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in August
40 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in July
41 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in June