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40 orthopedic devices receive FDA 510(k) clearance in October Featured

Written by  Laura Dyrda | Monday, 13 November 2017 10:03
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The FDA granted 40 orthopedic-and spine-related device clearances in October.

 

1. Shanghai Sanyou Carmen Cervical Fusion System from Shanghai Sanyou Medical.

 

2. Novos-Nail Limb Lengthening System from Smith & Nephew.

 

3. Myknee PPS-Pin Positioners from Medacta International.

 

4. iTotal Family Reusable Instrument Tray from ConforMIS.

 

5. Tahoe Uni Knee System from Consensus Orthopedics.

 

6. Medacta Shoulder System from Medacta International.

 

7. Bridalveil Occipital Cervical Thoracic System from Astura Medical.

 

8. G3 Active Plate Miniature System from Genesis Fracture Care.

 

9. 3M Bair Hugger Model 675 Total Temperature Management System from 3M Company.

 

10. Acapella Cervical Spacer System from ChoiceSpine.

 

11. Mikron Spinal Fixation System from Mikron Makina Sanayi Ticaret.

 

12. Intellijoint Hip Generation 2B System from Intellijoint Surgical.

 

13. M-ARS ACL: Anatomic Ribbon Surgery System from Medacta International.

 

14. ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System from Medtronic Sofamor Danek.

 

15. Trident II Acetabular System from Howmedica Osteonics.

 

16. Intra-Lock Bone Fixation System from Intra-Lock International.

 

17. Cortina Lumbar Cage System from NeuroStructures.

 

18. Kyphon Xpede Bone Cement, CD Horizon Fenestrated Screw Set from Medtronic.

 

19. Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap from Stryker.

 

20. NuVasive Modulus XLIF Interbody System from NuVasive.

 

21. BioWick X Implant with Driver from Cayenne Medical.

 

22. ReUnion Reversible Fracture System, ReUnion Reverse Shoulder Arthroplasty System, ReUnion Total Shoulder Arthroplasty System from Stryker Trauma.

 

23. iFuse Implant System – iFuse Navigation from SI-BONE.

 

24. Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System from Stryker Orthopaedics.

 

25. Ortus Expandable Lumbar Interbody Fusion System from Atlas Spine.

 

26. NuVasive Modulus TLIF Interbody System from NuVasive.

 

27. Fortilink Interbody Fusion System with TETRAfuse 3D Technology from RTI Surgical.

 

28. AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert from Encore Medical.

 

29. Biomet Bone Cement from Biomet.

 

30. Silco Fixation System from Globus Medical.

 

31. AnyPlus Spinal Fixation System from GS Medical.

 

32. Liberty Anterior Cervical Plate from Valorus Spine.

 

33. Treace Medical Concepts Compression Screw System from Treace Medical Concepts.

 

34. Smith & Nephew Anthology Afit Hip Stem from Smith & Nephew.

 

35. Xia 4.5 Spinal System, Power Adaptor Instrument Accessory from Stryker.

 

36. CosmoLock Pedicle Screw System from Kalitec Direct.

 

37. SeaSpine Ventura NanoMetalene System from SeaSpine Orthopedics.

 

38. IVA Cage Ti from Huvexel.

 

39. Viper Prime Screws, Viper Prime Screws with Fenestrations, Expedium Verse Screws with Fenestrations from Medos International.

 

40. Klassic HD Hooded Acetabular Insert with E-link Poly, Klassic HD Low Profile Acetabular Insert with E-Link Poly from Total Joint Orthopedics.

 

More articles on FDA clearances:
35 orthopedic devices receive FDA 510(k) clearance in September
57 orthopedic devices receive FDA 510(k) clearance in August
33 orthopedic devices receive FDA 510(k) clearance in July

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