Regulatory

52 spine, orthopedic devices receive FDA 510(k) clearance in July

Written by  Laura Dyrda 

The Food and Drug Administration granted 52 orthopedic- and spine-related device exemptions in July.

1. Choice Spine Lumbar Spacer System from Choice Spine.

2. Excia Total Hip System from Aesculap Implant Systems.

3. Skyhawk Lateral Plate System from Orthofix.

4. Endoskeleton TL Interbody Fusion Device from Titan Spine.

5. View Plating System, Reduce Fracture Plating System, Bone Screw from Icon Orthopedic Concepts.

6. Aesculap Optilene Nonabsorbable Suture from Aesculap.

7. Range/Mesa/Denali Spinal System from K2M.

8. Restoris Porous Partial Knee System from MAKO Surgical.

9. FixFit Intervertebral Body Fusion Device from Expanding Orthopedics.

10. Biofoam Bone Wedge from Wright Medical Technology.

SEE THE REST AT BECKER’S

 

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Josh Sandberg

Josh Sandberg is the President of Ortho Sales Partners and Partner for The De Angelis Group. He also serves as Co-Founder and Editor of OrthoSpineNews.

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