15 Spine Devices Receive FDA 510(k) Clearance in May

Spinal Tech

SurgeonThe Food and Drug Administration granted 15 spine-related medical device clearances in May.
1. ZygaFix Spinal Facet Screw System from X-Spine Systems.

2. Sterispine PS Pedicle Screw from Safe Orthopaedics.

3. Azure Anterior Cervical Plate System from Orthofix.

4. Range Spinal System, Small Suture from K2M.

5. Response Spine System from Orthopaedics Corp.

6. Integra Laminoplasty System from SeaSpine.

7. CREO Stabilization System from Globus Medical.

8. IMSE P-TLIF from Institute of Musculoskeletal Science.

9. Latis Spacer from Globus Medical.

10. MECTALIF Anterior Standalone from MEDACTA International.

11. Synthes Synflate Vertebral Balloon System from Synthes.

12. Solanas Posterior Stabilization System from Alphatec Spine.

13. Synthes Syncage Evaluation Spacer from Synthes.

14. Providence Cervical Cage from Providence Medical Technology.

15. Lanx Spinal Fixation System from Lanx.

More Articles on Spine Devices:

NuVasive Announces Global Launch of Posterior Lumbar Interbody Fusion Device

FDA Panel Recommends Down Classifying Rigid Pedicle Screws to Class II Device

TranS1 Renamed Baxano Surgical, Relocates Headquarters to Raleigh


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