The Food and Drug Administration granted 510(k) clearance to 19 spine-related devices in August, according to an FDA report. 1. Mesa Spinal System (Keystone Rods) from K2M.
2. Del Mar Monoaxial Pedicle Screw System from Phygen.
3. Vu C Pod Intervertebral Body Device from Theken Spine.
4. Care Back Pain Relieve Stimulator from ShenZhen Dongdixin Technology.
5. Stryker Spine Power Adapter (Accessory Instrument) from Stryker.
6. Perimeter C. Spinal System from Medtronic Sofamor Danek.
7. Crescent Spinal System Titanium from Medtronic Sofamor Danek.
8. Universal Clamp Spinal Fixation System from Zimmer Spine.
9. Romeo Posterior Osteosynthesis System from Spineart.
10. Infill Graft Delivery System from Pinnacle Spine Group.
11. Pyrenees Cervical Plate System from K2M.
12. Staxx XDL System from Spine Wave.
13. Polaris Spinal System from Biomet Spine.
14. LCCS Insulated Spinal Needle from LCCS Products.
15. Stremline Spinal System from Pioneer Surgical Technology.
16. Perimeter Interbody Fusion Device from Medtronic Sofamor Danek.
17. Chesapeake (Cervical Components) from K2M.
18. Pioneer Aspect Anterior Cervical Plate from Pioneer Surgical.
19. Daytona Anterior Cervical Cage from SpineNet.
Related Articles on Spine Device Clearances:
20 Spine Devices Receive FDA 510(k) Clearance in July
12 Spine Devices Receive FDA 510(k) Clearance in June
15 Spine Devices Receive FDA 510(k) Clearance in May
2. Del Mar Monoaxial Pedicle Screw System from Phygen.
3. Vu C Pod Intervertebral Body Device from Theken Spine.
4. Care Back Pain Relieve Stimulator from ShenZhen Dongdixin Technology.
5. Stryker Spine Power Adapter (Accessory Instrument) from Stryker.
6. Perimeter C. Spinal System from Medtronic Sofamor Danek.
7. Crescent Spinal System Titanium from Medtronic Sofamor Danek.
8. Universal Clamp Spinal Fixation System from Zimmer Spine.
9. Romeo Posterior Osteosynthesis System from Spineart.
10. Infill Graft Delivery System from Pinnacle Spine Group.
11. Pyrenees Cervical Plate System from K2M.
12. Staxx XDL System from Spine Wave.
13. Polaris Spinal System from Biomet Spine.
14. LCCS Insulated Spinal Needle from LCCS Products.
15. Stremline Spinal System from Pioneer Surgical Technology.
16. Perimeter Interbody Fusion Device from Medtronic Sofamor Danek.
17. Chesapeake (Cervical Components) from K2M.
18. Pioneer Aspect Anterior Cervical Plate from Pioneer Surgical.
19. Daytona Anterior Cervical Cage from SpineNet.
Related Articles on Spine Device Clearances:
20 Spine Devices Receive FDA 510(k) Clearance in July
12 Spine Devices Receive FDA 510(k) Clearance in June
15 Spine Devices Receive FDA 510(k) Clearance in May