The Food and Drug Administration issued 28 orthopedic- and spine-related 510(k) clearances in August, according to an FDA report.
1. Vega Span Sinous Process Plate System from SpineFrontier.
2. NovaBone Putty Bioactive Synthetic Bone Graft.
3. Jet-X Bar System Clamps and Posts Reprocessing from Smith & Nephew.
4. VU APOD Intervertebral Body Fusion Device from Theken Spine.
5. Taperloc Complete from Biomet.
6. Motionloc screw for NCB Polyaxial Locking Plating System from Zimmer Holdings.
7. Staxx XD System from Spine Wave.
8. Smith & Nephew Instrument Trays.
9. Interface Acetabular System and Acetabular Insert +4 Offset from Omni Life Science.
10. 2.7/3.5MM VA-LCP Anterio Clavicle Plate System from Synthes.
11. Trimed X-Fix.
12. ITotal CR Knee Replacement System from Conformis.
13. Parallax Contour Vertebral Augmentation Device from ArthroCare.
14. Pathfinder II, Minimally Invasive Pedicle Screw System 3500 Series from Zimmer Spine.
15. Advanced Vertebral Solutions Express BFD.
16. STALIF Midline from Centeniel Spine.
17. GMK Revision Knee System from Medacta International.
18. Smith & Nephew Circular Fixation System from Smith & Nephew.
19. Construx Mini PEEK Spacer System from Orthofix.
20. CD Horizon Spinal System from Medtronic Sofamor Danek.
21. Mini Maxlock Extreme Plating System from Orthohelix Surgical Designs.
22. Apex Knee Modular Tibia System from Omnlife Science.
23. DePuy Universal Gription TF Cones from DePuy Orthopaedics.
24. LDR Spine USA C-Plate, TL Anterior Cervical Plate System from LDR Spine.
25. TSRH Spinal System from Medtronic Sofamor Danek.
26. SpineSmith Cynch Spinal System, Visualif Interbody Fusion Implant System from SpineSmith Partners.
27. Maxlock Extreme Extremities Plating System Distal Radius Plates and Screws from Orthohelix Surgical Designs.
28. Primalok Facet Fixation System from Osteomed.
Read the FDA report on September clearances.
Read other coverage on FDA clearances:
- 32 Orthopedic and Spine Devices Receive FDA Clearance in August
- 26 Orthopedic and Spine Devices Receive FDA Clearance in July
1. Vega Span Sinous Process Plate System from SpineFrontier.
2. NovaBone Putty Bioactive Synthetic Bone Graft.
3. Jet-X Bar System Clamps and Posts Reprocessing from Smith & Nephew.
4. VU APOD Intervertebral Body Fusion Device from Theken Spine.
5. Taperloc Complete from Biomet.
6. Motionloc screw for NCB Polyaxial Locking Plating System from Zimmer Holdings.
7. Staxx XD System from Spine Wave.
8. Smith & Nephew Instrument Trays.
9. Interface Acetabular System and Acetabular Insert +4 Offset from Omni Life Science.
10. 2.7/3.5MM VA-LCP Anterio Clavicle Plate System from Synthes.
11. Trimed X-Fix.
12. ITotal CR Knee Replacement System from Conformis.
13. Parallax Contour Vertebral Augmentation Device from ArthroCare.
14. Pathfinder II, Minimally Invasive Pedicle Screw System 3500 Series from Zimmer Spine.
15. Advanced Vertebral Solutions Express BFD.
16. STALIF Midline from Centeniel Spine.
17. GMK Revision Knee System from Medacta International.
18. Smith & Nephew Circular Fixation System from Smith & Nephew.
19. Construx Mini PEEK Spacer System from Orthofix.
20. CD Horizon Spinal System from Medtronic Sofamor Danek.
21. Mini Maxlock Extreme Plating System from Orthohelix Surgical Designs.
22. Apex Knee Modular Tibia System from Omnlife Science.
23. DePuy Universal Gription TF Cones from DePuy Orthopaedics.
24. LDR Spine USA C-Plate, TL Anterior Cervical Plate System from LDR Spine.
25. TSRH Spinal System from Medtronic Sofamor Danek.
26. SpineSmith Cynch Spinal System, Visualif Interbody Fusion Implant System from SpineSmith Partners.
27. Maxlock Extreme Extremities Plating System Distal Radius Plates and Screws from Orthohelix Surgical Designs.
28. Primalok Facet Fixation System from Osteomed.
Read the FDA report on September clearances.
Read other coverage on FDA clearances:
- 32 Orthopedic and Spine Devices Receive FDA Clearance in August
- 26 Orthopedic and Spine Devices Receive FDA Clearance in July