35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in MayWritten by Laura Miller | June 15, 2011
The Food and Drug Administration issued 35 orthopedic- and spine-related 510(k) clearances in May, according to an FDA report.
1. Durafiber AG from Smith & Nephew.
2. Biomet Sports Medicine Sternal Closure System from Biomet.
3. Corin Trinity Acetabular System With HXLPE Liners from Corin USA.
4. Piccolo Composite Nailing System from Carbofix Orthopaedics.
5. MAC Male Adapter from Biomet Trauma.
6. Endofuse Intra-Osseous Fusion System from Wright Medical Technology.
7. HLS KneeTec System from Tornier.
8. Issys LP Spinal Fixation System from Custom Spine.
9. Ellipse Occipito-Cervico-Thoracic Spinal System from Globus Medical.
10. Tornier Biofiber Scaffold from Tornier.
11. Gladiator Plasma Classic Hip System from Wright Medical Technology.
12. Streamline TL Spinal System from Pioneer Surgical Technologies.
13. SeaSpine Spacer System from SeaSpine.
14. Cougar LS Lateral Gave System from Johnson & Johnson.
15. Exatech Equinoxe Cuff Tear Arthroplasty Head from Exactech.
16. Sterile Storm Operating Kit from Intelligent Orthopaedics.
17. Dash Knee from Brainlab.
18. Rog Suture Anchor 5.5 MM, 2.9MM from Rog Sports Medicine.
19. Synthes Homeostatic Bone Putty from Synthes USA.
20. Stryker Patient Specific Cutting Guide from Stryker.
21. Rog Knotless Suture Anchor from Rog Sports Medicine.
22. Zenius Spinal System from Medyssey.
23. Zimmer Periarticular Locking Plate System from Zimmer.
24. Intercontinental Plate-Spacer from Globus Medical.
25. K2M COCR Wire from K2M.
26. TSRH Spinal System from Medtronic Sofamor Danek.
27. Synthes 3.5MM Low Profile Cortical Screw from Synthes USA.
28. Total Shoulder System from Shoulder Innovations.
29. Ascent Posterior Occipital Thoracic System from Orthofix.
30. ABG II Monolithic Hip System from Stryker.
31. Leucadia Pedicle Screw System from Phygen.
32. Tiger Spine System from CoreLink.
33. Nanotack Suture Anchor 1.4MM from Pivot Medical.
34. Interfuse T Intervertebral Body Fusion Device from Vertebral Technologies.
35. 5.5/5.6MM Spartan PEEK Suture Implant from ArthroCare.
Read the report on FDA Clearances.
Related Articles on FDA Clearances:
34 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in April
56 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in March
36 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in February
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