The Food and Drug Administration issued 32 orthopedic- and spine-related 510(k) clearances in August, according to an FDA report.
1. Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts from Encore Medical.
2. Range Spinal System from K2M.
3. Ascension Total Plate System from Ascension Orthopedics.
4. Optetrak Logic Combination Tibial Tray from Exactech.
5. Exatech Equinoxe, Platform Fracture Stem.
6. 1-M Graduated Compression Anti-Embolism Stocking from I-Ming Sanitary Materials.
7. Synthes 2.4 MM/2.7MM Variable Angle LCP Forefoot/Middlefoot System.
8. Orthomap 3D 1.1 Module from Stryker.
9. Neotract Anchor System Model.
10. I.T.S. LRS Locking Reconstruction System from I.T.S. Implantant-Technologie System.
11. Wenzel Spine Verilift Interbody Fusion System.
12. Modification to Synthes Matrix System.
13. Lanx Spinal Fixation System.
14. Versitomic ACL Flexible Reamer System Sterilization Tray from T.A.G. Medical Products.
15 Evaluation Unicondylar Knee System from Wright Medical Technology.
16. Quantum/Streamline TL MIS Spinal System from Pioneer Surgical Technology.
17. Atlas Spine Pivoting System.
18. Quantum/Strreamline Spinal System from Pioneer Surgical Technology.
19. AVA Navigator PEEK Spacers from Stryker.
20. Kyph X HV-R Bone Cement from Medtronic.
21. AVS A-LAT PEEK Spacers from Stryker.
22. Stainless Steel Spinal System from Theken Spine.
23. Lanx Facet Screw System.
24. Primal OK Interspinous Fusion System from Osteomed.
25. Zimmer DTO Pin Press Instrument.
26. Mantis Spinal System & Mantis Redux Spinal System from Stryker.
27. TranS1 Lateral Invertebral Fusion Device.
28. Journey CR Knee System from Smith & Nephew.
29. Inbone II Total Ankle Replacement from Wright Medical.
30. TenZing System from Mazor Surgical Technologies.
31. Ascension Modular Total Shoulder System.
32. Expedium Spine System from Medos International Sarl.
Read the FDA report on August clearances.
1. Reverse Shoulder Prosthesis Monoblock Stem, Reverse Shoulder Prosthesis Humeral Inserts from Encore Medical.
2. Range Spinal System from K2M.
3. Ascension Total Plate System from Ascension Orthopedics.
4. Optetrak Logic Combination Tibial Tray from Exactech.
5. Exatech Equinoxe, Platform Fracture Stem.
6. 1-M Graduated Compression Anti-Embolism Stocking from I-Ming Sanitary Materials.
7. Synthes 2.4 MM/2.7MM Variable Angle LCP Forefoot/Middlefoot System.
8. Orthomap 3D 1.1 Module from Stryker.
9. Neotract Anchor System Model.
10. I.T.S. LRS Locking Reconstruction System from I.T.S. Implantant-Technologie System.
11. Wenzel Spine Verilift Interbody Fusion System.
12. Modification to Synthes Matrix System.
13. Lanx Spinal Fixation System.
14. Versitomic ACL Flexible Reamer System Sterilization Tray from T.A.G. Medical Products.
15 Evaluation Unicondylar Knee System from Wright Medical Technology.
16. Quantum/Streamline TL MIS Spinal System from Pioneer Surgical Technology.
17. Atlas Spine Pivoting System.
18. Quantum/Strreamline Spinal System from Pioneer Surgical Technology.
19. AVA Navigator PEEK Spacers from Stryker.
20. Kyph X HV-R Bone Cement from Medtronic.
21. AVS A-LAT PEEK Spacers from Stryker.
22. Stainless Steel Spinal System from Theken Spine.
23. Lanx Facet Screw System.
24. Primal OK Interspinous Fusion System from Osteomed.
25. Zimmer DTO Pin Press Instrument.
26. Mantis Spinal System & Mantis Redux Spinal System from Stryker.
27. TranS1 Lateral Invertebral Fusion Device.
28. Journey CR Knee System from Smith & Nephew.
29. Inbone II Total Ankle Replacement from Wright Medical.
30. TenZing System from Mazor Surgical Technologies.
31. Ascension Modular Total Shoulder System.
32. Expedium Spine System from Medos International Sarl.
Read the FDA report on August clearances.