35 spine, orthopedic devices receive FDA 510(k) clearance in June

Spinal Tech

The Food and Drug Administration cleared 35 orthopedic and spine devices in June.

1. Virage OCT Spinal Fixation System from Zimmer Spine.

 

2. SMR TT Metal Back Glenoid from LimaCroporate.

 

3. Range Spinal System from K2M.

 

4. Biomet Cannulated Screw System from Biomet.

 

5. SteriSpine PS from Safe Orthopaedics.

 

6. BN Lumbar Cage System from Medyssey USA.

 

7. RSP Humeral Socket Insert from DJO Global.

 

8. Stryker KWIC Needle from Orthovita.

 

9. OIC Variable Angle Small Fragment Locking Plate System from Orthopaedic Implant Company.

 

10. Gryphon BR Anchor With Permacord from DePuy Mitek.

 

11. Mastergraft Putty from Medtronic Sofamor Danek USA.

 

12. A.I.M. Knotless Meniscal Repair Device from Anchor Innovation Medical.

 

13. MasterSL Femoral Stem from LimaCorporate.

 

14. Chesapeake Spinal System from K2M.

 

15. Meta-C Cervical Plate from Medacta.

 

16. U2 Femoral Component from United Orthopedic.

 

17. Acumed Hand Fracture System from Acumed.

 

18. Bengal System, Bengal Stackable System, Concorde Bullet Lumbar, Concorde Inline Lumbar, Cougar System from Medos International.

 

19. U2 Femoral Component, CR, Cemented from United Orthopedic.

 

20. Tornier Aequalis Adjustable Reverse Shoulder System from Tornier.

 

21. CosmoLock Pedicle Screw System from Kalitec Direct.

 

22. Variax 2 One Third Tubular Plating System from Stryker Trauma.

 

23. Axos 3 TI Locking Plate System from Stryker Trauma.

 

24. Diamond Rattlesnake System from Eminent Spine.

 

25. Coroent Thoracolumbar Implants from NuVasive.

 

26. Kangli Pedicle Screw Spinal System from SuZhou Kangli Orthopaedics Instrument.

 

27. Sure-Lok C Extended TAB Pedicle Screw System from Precision Spine.

 

28. Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior Cervical Plate and Screws from Nexxt Spine.

 

29. Multifilament Stainless Steel Sutures With Crimps from Pontis Orthopaedics.

 

30. NovoHip Bipolar Head/NovoHip Vitamin E Liner/Bone Screws/Hole Plug from Novosource.

 

31. SpineVision Lumis Cannulated Pedicle Screw Fixation System from SpineVision.

 

32. Delta TT Acetabular System from Limacorporate.

 

33. Exactech Tapered Wedge Femoral Stem from Exactech.

 

34. Precice Trauma Nail System from Ellipse Technologies.

 

35. iTotal Posterior Stabilized Knee Replacement System from ConforMIS.

 

 

More Articles on FDA Clearances:
39 spine, orthopedic devices receive FDA 510(k) clearance in May
44 spine, orthopedic devices receive FDA 510(k) clearance in April
44 spine, orthopedic devices receive FDA 510(k) clearance in March

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