The Food and Drug Administration cleared 20 spine-related devices in July, according to an FDA report.
1. Plateau Spacer System from Life Spine.
2. Viper Systems from Johnson & Johnson.
3. Solanas Avalon Posterior Fixation System from Alphatec Spine.
4. Atlas Spine Pedicle Screw System from Atlas Spine.
5. Exactech Gibralt Spinal System from Exactech.
6. Capstone R. Spinal System from Medtronic Sofamor Danek.
7. Staxxsd System from Spine Wave.
8. Pathway from Custom Spine.
9. Eturn Spinal Implant from Icotec.
10. Genesys Spine Tilock System from Genesys Spine.
11. DSC/ALF Spinal System from Sintea Plastek.
12. SImmetry Sacroiliac Joint Fusion System from Zyga Technologies.
13. Rexious Spinal Fixation System from Dio Medical.
14. Venus Cervical Spinal Fixation System from L&K Biomed.
15. Cervical Cage from EiserTech.
16. NuVasive Anterior Lumbar Plate System from NuVasive.
17. GSO ACP1 Anterior Lumbar Plate System from Gold Standard Orthopedics.
18. 3.7MM/5.0MM Dynamic Locking Screw from Synthes USA.
19. Apex Spine System from SpineCraft.
20. Synthes Sternal ZipFix System from Synthes.
Read the full medical device clearance report from the FDA.
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2. Viper Systems from Johnson & Johnson.
3. Solanas Avalon Posterior Fixation System from Alphatec Spine.
4. Atlas Spine Pedicle Screw System from Atlas Spine.
5. Exactech Gibralt Spinal System from Exactech.
6. Capstone R. Spinal System from Medtronic Sofamor Danek.
7. Staxxsd System from Spine Wave.
8. Pathway from Custom Spine.
9. Eturn Spinal Implant from Icotec.
10. Genesys Spine Tilock System from Genesys Spine.
11. DSC/ALF Spinal System from Sintea Plastek.
12. SImmetry Sacroiliac Joint Fusion System from Zyga Technologies.
13. Rexious Spinal Fixation System from Dio Medical.
14. Venus Cervical Spinal Fixation System from L&K Biomed.
15. Cervical Cage from EiserTech.
16. NuVasive Anterior Lumbar Plate System from NuVasive.
17. GSO ACP1 Anterior Lumbar Plate System from Gold Standard Orthopedics.
18. 3.7MM/5.0MM Dynamic Locking Screw from Synthes USA.
19. Apex Spine System from SpineCraft.
20. Synthes Sternal ZipFix System from Synthes.
Read the full medical device clearance report from the FDA.
Related Articles on Spine Devices:
12 Spine Devices Receive FDA 510(k) Clearance in June
15 Spine Devices Receive FDA 510(k) Clearance in May
13 Spine Devices Receive FDA 510(k) Clearance in April