The Food and Drug Administration issued 15 spine-related 510(k) clearances in December, according to an FDA report.
1. NuVasive Spherx II-Mas Deformity Spinal System from NuVasive.
2. Concorde Curve System from DePuy Spine.
3. Laminolasty Plating System from Aesculap Implant System.
4. Patriot Transcontinental M Spacers from Globus Medical.
5. S. 100 Pedicle Screw from Renovis Surgical Technologies.
6. Viper System, Expedium System from DePuy Spine.
7. Genesys Spine Interbody Fusion System from Genesys Spine.
8. Apex Spine System With COCR Rods from SpineCraft.
9. Vu CPOD Intervertebral BODU Fusion Device from Musculoskeletal Clinical Regulators.
10. Posterior Lateral Plates from DePuy Orthopaedics.
11. Novel Spinal Fixation and Adjustable Bridge System from Medyssey Co.
12. Synthes Zero-P from Synthes Spine.
13. Interia Pedicle Screw System from Nexxt Spine.
14. TSRH Spinal System from Medtronic Sofamor Danek.
15. Zenius Spinal System from Medyssey Co.
Read the full FDA report on medical device clearances from December.
Read other coverage on orthopedic and spine device clearances:
- 49 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in December
- 35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in November
1. NuVasive Spherx II-Mas Deformity Spinal System from NuVasive.
2. Concorde Curve System from DePuy Spine.
3. Laminolasty Plating System from Aesculap Implant System.
4. Patriot Transcontinental M Spacers from Globus Medical.
5. S. 100 Pedicle Screw from Renovis Surgical Technologies.
6. Viper System, Expedium System from DePuy Spine.
7. Genesys Spine Interbody Fusion System from Genesys Spine.
8. Apex Spine System With COCR Rods from SpineCraft.
9. Vu CPOD Intervertebral BODU Fusion Device from Musculoskeletal Clinical Regulators.
10. Posterior Lateral Plates from DePuy Orthopaedics.
11. Novel Spinal Fixation and Adjustable Bridge System from Medyssey Co.
12. Synthes Zero-P from Synthes Spine.
13. Interia Pedicle Screw System from Nexxt Spine.
14. TSRH Spinal System from Medtronic Sofamor Danek.
15. Zenius Spinal System from Medyssey Co.
Read the full FDA report on medical device clearances from December.
Read other coverage on orthopedic and spine device clearances:
- 49 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in December
- 35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in November