21 Spine Devices Receive FDA 510(k) Clearance in NovemberWritten by Laura Miller | December 21, 2011
The Food and Drug Administration granted 21 spine-related devices 510(k) clearance in November, according to an FDA report.
1. Leucadia MIS Pedicle Screw System from Phygen.
2. Synthes Zero-P Variable Angle from Synthes Spine.
3. Prow Fusion from NLT Spine.
4. Calix PC Spinal Implant System from X-Spine Systems.
5. Nanovis Intervertebral Body Fusion System from Nanovis.
6. Telamon PEEK Spinal System from Medtronic Sofamor Danek.
7. Acufex Director Application Anatomic Guide System from Smith & Nephew Endoscopy.
8. Anatomic PEEK Cervical Fusion System from Medtronic Sofamor Danek.
9. Sterispineps Pedicle Screw from Safe Orthopaedics.
10. Raptor Facet Fixation System from Alphatec Spine.
11. Rhausler Plage Anterior Cervical Fusion System from Rhausler.
12. Synthes USS Connectors from Synthes Spine.
13. S4 Spinal System from Aesculap Implant System.
14. PASS LP Spinal System from Medicrea International.
15. Gibralt Spine Systems Facet Screw from Exactech.
16. CD Horizon Spinal System from Medtronic Sofamor Danek USA.
17. Clydesdales Spinal System from Medtronic Sofamor Danek USA.
18. DePuy Pulse Anterior Cervical Plate System from Medos Interational Sarl.
19. Devine Spinal System from Changzhou Orthmed Medical Instruments.
20. Zavation Spinal System from Zavation.
21. Trabecular Metal Fusion Device from Zimmer Spine.
Related Articles on Spine Surgery:
10 Cost Benchmarks for Outpatient Cervical Spine Surgery
Where Spine Research is Headed: 5 Points From Dr. Frank Phillips
Building a Foundation for Scoliosis Treatment: 3 Important Studies
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