The Food and Drug Administration granted 25 orthopedic- and spine-related devices 510(k) clearance in September, according to an FDA report.
1. Bigliani/Flatow The Complete Shoulder Solution from Zimmer.
2. Helicon Hip System, Femoral Stem from TGM Medical.
3. Pilot Spinal System from Life Spine.
4. Unite Biomatrix from Synovis Orthopedic & Woundcare.
5. A-Wedge Anterior Interbody System from SpineWorks.
6. IFS Profile Plates, Screws and Washers from Internal Fixation Systems.
7. MRGFUS Pelvic Coil Model 1.0 from Insighntech.
8. Endoskeleton TAS from Titan Spine.
9. Smith & Nephew RJ Constrained Liners from Smith & Nephew.
10. Toshiba 3T Extra Large Knee Coil from Toshiba.
11. Discovery from Intuitive Spine.
12. Medical Concepts Interbody Fusion System from Medical Concepts.
13. Captiva Spine CapLx II Spinal Fixation System from QualiReg Resources.
14. CD Horizon Spinal System from Medtronic Sofamor Danek.
15. Sure Lok Mini Posterior Cervical/Upper Thoracic System from Spinal USA.
16. Journey II BCS Knee System from Smith & Nephew.
17. Turon RSP Socket Shell-Neutral from Encore Medical.
18. Ortho Development Ceramic Femoral Head from Ortho Development.
19. Odalys Pedicle Screw System from Kalitec Direct.
20. Aiming Blocks for Variax Distal Radius Plates from Homedica Osteonics.
21. United 36MM Ceramic Femoral Head, Delta from United Orthopedic.
22. Pass LP Spinal System from Medicrae International.
23. Spineology PEEK Bullet Lumbar Interbody Fusion Device from Spineology.
24. Exeter Hip Stem from Homedica Osteonics.
25. Meta-Lock Suture Anchor System from Tarsus Medical.
Related Articles on FDA Clearances:
42 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in August
46 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in July
29 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in June
2. Helicon Hip System, Femoral Stem from TGM Medical.
3. Pilot Spinal System from Life Spine.
4. Unite Biomatrix from Synovis Orthopedic & Woundcare.
5. A-Wedge Anterior Interbody System from SpineWorks.
6. IFS Profile Plates, Screws and Washers from Internal Fixation Systems.
7. MRGFUS Pelvic Coil Model 1.0 from Insighntech.
8. Endoskeleton TAS from Titan Spine.
9. Smith & Nephew RJ Constrained Liners from Smith & Nephew.
10. Toshiba 3T Extra Large Knee Coil from Toshiba.
11. Discovery from Intuitive Spine.
12. Medical Concepts Interbody Fusion System from Medical Concepts.
13. Captiva Spine CapLx II Spinal Fixation System from QualiReg Resources.
14. CD Horizon Spinal System from Medtronic Sofamor Danek.
15. Sure Lok Mini Posterior Cervical/Upper Thoracic System from Spinal USA.
16. Journey II BCS Knee System from Smith & Nephew.
17. Turon RSP Socket Shell-Neutral from Encore Medical.
18. Ortho Development Ceramic Femoral Head from Ortho Development.
19. Odalys Pedicle Screw System from Kalitec Direct.
20. Aiming Blocks for Variax Distal Radius Plates from Homedica Osteonics.
21. United 36MM Ceramic Femoral Head, Delta from United Orthopedic.
22. Pass LP Spinal System from Medicrae International.
23. Spineology PEEK Bullet Lumbar Interbody Fusion Device from Spineology.
24. Exeter Hip Stem from Homedica Osteonics.
25. Meta-Lock Suture Anchor System from Tarsus Medical.
Related Articles on FDA Clearances:
42 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in August
46 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in July
29 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in June