FDA Clears 14 More Orthopedic Devices in September

The FDA issued 14 more orthopedic-related 510(k) clearances in September, in addition to 13 September clearances reported earlier, according to a report by the FDA.

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The devices are the following:

1. Atlas Spine Spacer from Atlas Spine.

2. DBX, DBM Putty from MTF.

3. Diana Fusion Cage from Signus Medical.

4. Firebird Spinal Fixation System from Blackstone Medical.

5. Gso Pct Spinal System from Gold Standard Orthopaedics.

6. Mantis Redux Spinal System from Stryker Spine.

7. Modification to Beacon Stabilization System from Globus Medical.

8. Modification to CD Horizon Spinal System from Medtronic Sofamor Danek.

9. Modification to Expedium Spine System from DePuy Spine.

10. Perimeter Interbody Fusion Device from Medtronic Sofamor Danek.

11. Spinal USA Interbody Cages from Spinal USA.

12. StaXX XD System from Spine Wave.

13. T2 Spinals System from Medtronic Sofamor Danek.

14. VLift-S Vertebral Body Replacement System from Stryker Spine.

Read the FDA’s report on September 2009 510(k) clearances.

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