10 spine devices receive FDA 510(k) clearance in June

Spinal Tech

The FDA cleared 10 spine related devices in June.


1. Spinal Fixation System from Shangdon Kangsheng Medical Device.
2. SpineFrontier Lumbar Interbody Fusion Device System from SpineFrontier.
3. F3D Cervical Stand-Alone Interbody Fusion System from CoreLink.
4. Medussa-PL Cage from Medyssey USA.
5. IlluminOss Bone Stabilization System from IlluminOss Medical.
6. Altus Spine Pedicle Screw System from Altus Partners.
7. Rigel 3DR Anterior Cervical Interbody Fusion System from MiRus.
8. SeaSpine Meridian System, SeaSpine Regatta Lateral System from SeaSpine Orthopedics.
9. Sapphire Spinal System, Sapphire X Anterior Cervical Plate Spinal System from Spinal Elements.
10. Centurion POCT System from Orthofix.

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