The Food and Drug Administration granted 39 orthopedic- and spine-related device clearances in August.
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1. RigidLoop Fixation Device from DePuy Mitek.
2. Normed Ankle Fix System 4.0 and Normed Ankle Fix Plus System 4.0 from Normed Mexizin-Technik.
3. Smith & Nephew SureShot Distal Targeting System V3.0 from Smith & Nephew.
4. Exp Tibial inserts and Patellar Components for the Proven GEN-FLEX Knee System from Stekast Company.
5. Seviin Fracture Shoulder from InGen Orthopedics.
6. Signature Personalized Patient Care System—Glenoid Guide System from Biomet.
7. The Kinegraph VMA Software Version 2.0 from Ortho Kinematics.
8. CD Horizon Spinal System from Medtronic Sofamor Danek USA.
9. Integra Titanium Bone Wedge from Ascension Orthopedic.
10. Firebird Spinal Fixation System from Orthofix.
11. Expandable Lumbar Interbody System from NuVasive.
12. PediGuard Nerve Detector System from SpineGuard.
13. Osseus Black Diamond Pedicle Screw System from Osseus Fusion Systems.
14. Metallic Locking Compression Bone Plates and Screws System from Tianjin
Walkman Biomaterial.
15. Caplox II Pedicle Screw System/Towerlox Pedicle Screw System from Captiva
Spine.
16. ArthroCare Head and Neck Coblation Wand from ArthroCare.
17. Facet Screw System from Spinal USA.
18. Surfix Interspinous Fusion System from JG Spine.
19. Capsure PS System from Spine Wave.
20. Core Pedicle Screw System from Core-Nexus.
21. Zimmer ATS 4000TS Automatic Tourniquet System from Zimmer.
22. Humelock II Cemented Shoulder System from FX Solutions.
23. S4C Navigation Instruments from Aesculap Implant System.
24. C-Fuse Cervical Intervertebral Body Fusion System from Southern Spine.
25. Irix-C Cervical Integrated Fusion System from X-Spine Systems.
26. Kinex Bioactive from Globus Medical.
27. ABG III Monolithic Hip Stem from Howmedica Osteonics.
28. Quattro GL Suture Anchor from Cayenne Medical.
29. Staxx IBL System from Spine Wave.
30. CAS PSI Shoulder from Zimmer CAS.
31. Spondylolisthesis Spinal Fixation, Spinal Pedicle Fixation from Accel Spine.
32. Pagoda Pedicle Screw System from Ortho Development.
33. GMK Full PE Tibial Components from Medacta International.
34. Mountaineer Oct. Spinal Surface from Medos International SARL.
35. Flower Small and Medium Implant Set from Flower Orthopedics.
36. ArthroCare Coblator IQ DLR Spinewand from ArthroCare.
37. Avenir Cemented Hip Stem from Zimmer GMBH.
38. Tempus Cervical Plate System from NeuroStructures.
39. Lliad, Kora, Zenius Pedicle Screw System from Medyssey USA.
More Articles on Spine Clearances:
12 Spine Devices Receive FDA 510(k) Clearance in July
11 Spine Devices Receive FDA 510(k) Clearance in June