31 orthopedic & spine devices receive FDA 510(K) clearance in June

Spinal Tech

The Food and Drug Administration granted 31 orthopedic- and spine-related device clearances in June.

1. Lucent Intervertebral Body Fusion Device from Spinal Elements.
2. Spinal Jaxx Interbody Fusion Device from NeuroPro Spinal JAXX.
3. DSG Threaded Drill System from SpineGuard.
4. FitRite Total Hip Arthroplasty System from Excera Orthopedics.
5. Logical C-Series Acetabular Shell from Signature Orthopaedics.
6. MySpine Pedicle Screw Placement Guides from Medacta.
7. Lateral Spine Truss System from 4Web.
8. AnyPlus Cervical PEEK Cage System from GS Medical.
9. The Life Spine Subtalar Implant System from Life Spine.
10. Additive Orthopaedics Hammertoe Correction System from Additive Orthoapedics.
11. dynaMX Nitinol Compression Screw from MX Orthopedics.
12. Blueprint Patient Specific Instrumentation from Tornier.
13. iFuse Implant System from SI-BONE.
14. Gibralt Spine System and Gibralt Occipital Spine System from Exactech.
15. ATTUNE Revision Knee System from DePuy.
16. ZUK Select Knee System from Smith & Nephew.
17. Thunderbolt Minimally Invasive and Lancer Open Pedicle Screw System from ChoiceSpine.
18. PressON Pro Spinal Fixation System from Nexus Spine.
19. Nanovis Intervertebral Body Fusion System and FortiCore from Nanovis.
20. CoRoent Ti-C System from NuVasive.
21. F1 MPS Modular Pedicle Screw System from Degen Medical.
22. Aequalis PerFORM+ Shoulder System from Tornier.
23. NuVasive Reline System from NuVasive.
24. NeoView Plating System from In2Bones.
25. Milagro Advance PEEK Interference Screw from Medos International.
26. Cervical Stand Alone System from Orthofix.
27. Arsenal Spinal Fixation System from Aphatec Spine.
28. ConforMISA iTotal Cruciate Retaining Knee Replacement System from ConforMIS.
29. SMR Shoulder System from Lima Corporate.
30. hipEOS from ONEFIT Medical.
31. Arthrosurface Bone Screws from Arthrosurface.

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