21 Spine Devices Receives FDA 510(k) Clearance in October

Spinal Tech

The Food and Drug Administration granted 21 spine-related 510(k) medical device clearances in October, according to an FDA report.


1. Sovereign Spinal System from Medtronic.

2. Zimmer Periarticular Screws from Zimmer.

3. Range Spinal System (Mesa and Denali) from K2M.

4. Concorde Bullet Spinal System from Johnson & Johnson.

5. SFC Vertebral Body Replacement from Konigsee Implantate.

6. Cornerstone PSR Cervical Fusion System from Medtronic Sofamor Danek.

7. Mahe Perfect Spine-Pedicle Screw System from Mahe Medical.

8. GS Medical AnyPlus Peek Lumbar Cages from GS Medical.

9. Zyston Straight Spacer System from Biomet Spine.

10. Everyway Low Back Pain Relief System from Everyway Medical Instruments.

11. SmartLoc Spinal Fixation System from A-Spine Asia.

12. Apclo Pedicle Screw Systems from Atlas Spine.

13. Synthes XRL from Synthes Spine.

14. Enspire Debrider System from Spine View.

15. CD Horizon Spinal System from Medtronic.

16. Venus Interbody Fixation System—Venus PLIF/TLIF, ALIF Peek Cage from L&K Biomed.

17. Lateral Superior Clavicle Plate, Left and Right; Midshaft Superior Clavicle Plate, Left and Right; Anterior Clavicle Plate from Advanced Orthopaedic Solutions.

18. Expedium Spine System from Johnson & Johnson.

19. BoneBac T-PLIF Intervertebral Body Fusion Device System from Thompson MIS.

20. Synthes Sternal Fixation System from Synthes.

21. Invizia Anterior Cervical Plate System from Zimmer Spine.

Related Articles on Spine Device Clearances:

11 Spine Devices Receive FDA 510(k) Clearance in September

19 Spine Devices Receive FDA 510(k) Clearance in August

20 Spine Devices Receive FDA 510(k) Clearance in July



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