The Food and Drug Administration issued 22 spine device 510(k) clearances in March, according to an FDA report.
1. Laguna Pedicle Screw System from Phygen.
2. Concorde Bullet Cage System from Johnson & Johnson.
3. Zenith Pedicle System from Apollo Spine.
4. Trio Trauma Spinal System from Stryker.
5. Fluoromap Software, 9" Fluorodisc (Belt), 12" Fluoro Disc (Belt), Close Tube Clip from Stryker.
6. Palla M Spinal System from Korea Bone Bank.
7. Quantum Spinal System, Quantum MIS from Pioneer Surgical Technology.
6. Aleutian from K2M.
7. STCC from Cardinal Spine.
8. TranS1 AxiaLIF+ from TranS1.
9. Altum Anterior Cervical Plate form SpineCraft.
10. Aaxter A3 Posterior Spinal System from Aaxter.
11. Everest Spinal System from K2M.
12. Concorde Curve System from Johnson & Johnson.
13. Pezo Interbody Cage System from Ulrich.
14. Reverse Sacral Plates from Globus Medical.
15. Forza Spacer System from Orthofix.
16. Lanx Lateral from Lanx.
17. SImmetry Sacroiliac Joint Fusion System from Zyga.
18. Pioneer Spinal Process Fusion Plate from Pioneer Surgical Technology.
19. Lanx Spinal System from Lanx.
20. Syntec OS Spinal Fixation System from Syntec Scientific.
21. Capiva Spine FuseLox Cervical Cage from Capiva Spine.
22. Solus Anterior Lumbar Interbody Fusion Spinal Spacer System from Alphatec Spine.
Read the full report about medical devices receiving FDA Clearance in March.
Read other coverage on recent FDA clearances of spine devices:
- 23 Spine Devices Receive FDA 510(k) Clearance in February
- 18 Spine Devices Receive FDA 510(k) Clearance in January
1. Laguna Pedicle Screw System from Phygen.
2. Concorde Bullet Cage System from Johnson & Johnson.
3. Zenith Pedicle System from Apollo Spine.
4. Trio Trauma Spinal System from Stryker.
5. Fluoromap Software, 9" Fluorodisc (Belt), 12" Fluoro Disc (Belt), Close Tube Clip from Stryker.
6. Palla M Spinal System from Korea Bone Bank.
7. Quantum Spinal System, Quantum MIS from Pioneer Surgical Technology.
6. Aleutian from K2M.
7. STCC from Cardinal Spine.
8. TranS1 AxiaLIF+ from TranS1.
9. Altum Anterior Cervical Plate form SpineCraft.
10. Aaxter A3 Posterior Spinal System from Aaxter.
11. Everest Spinal System from K2M.
12. Concorde Curve System from Johnson & Johnson.
13. Pezo Interbody Cage System from Ulrich.
14. Reverse Sacral Plates from Globus Medical.
15. Forza Spacer System from Orthofix.
16. Lanx Lateral from Lanx.
17. SImmetry Sacroiliac Joint Fusion System from Zyga.
18. Pioneer Spinal Process Fusion Plate from Pioneer Surgical Technology.
19. Lanx Spinal System from Lanx.
20. Syntec OS Spinal Fixation System from Syntec Scientific.
21. Capiva Spine FuseLox Cervical Cage from Capiva Spine.
22. Solus Anterior Lumbar Interbody Fusion Spinal Spacer System from Alphatec Spine.
Read the full report about medical devices receiving FDA Clearance in March.
Read other coverage on recent FDA clearances of spine devices:
- 23 Spine Devices Receive FDA 510(k) Clearance in February
- 18 Spine Devices Receive FDA 510(k) Clearance in January