1. Hallmark Anterior Cervical Plate System
2. Hallmark five-level Cervical Plates
3. Peri-Loc Locking Hole Inserts and Cable Accessories from Smith & Nephew
4. Biolox Delta Ceramic Femoral Heads from Smith & Nephew
5. Aequalis Reversed Shoulder Prosthesis from Tornier
6. Stryker Switchpoint Infinity 3 Control System
7. Spartek Variable Angle Pedicle Screw Posterior Fusion System from
8. 2.7MM/3.5MM LCP Anterolateral Distal Tibia Plates from Synthes
9. Distraction Osteogenesis System, MR Conditional With Expanded Indications from Synthes
10. Exactech Euinoxe Proximal Humerous Fracture Plate System
11. Orthopedics HFN 125 Degree 9-13MM, 180MM, HFN 130 Degree 9-13 MM, HFN RH 125 Degree 9-13 MM from DePuy Orthopedics
12. Legion Porous + HA Tibial Baseplates from Smith & Nephew
13. Spinewand Surgical Device from Arthrocare
14. Synthes T-Pal Spacer
15. Diamond Anterior Cervical Plate System from Amendia
16. Variax Elbow System from Howmedica Osteonics
17. Variax Distal Radius Line Extensions of XXL Plates from Howmedica Osteonics
18. COCR Rods from Globus Medical
19. Polaris Spine System from EBI
20. Orthopediatrics Pediloc Tibia Plate System
21. Cardo Medical Ceramic Hip System
22. Titan TI Suture Anchor System from Arthrocare
23. Impix Alif Lumbar IBF from Medicrea Technologies
24. Regent Anterior Cervical Plate from Custom Spine
25. Biomet Forerunner Locking Plate System
26. Transcorp Trans-plate Anterior Cervical Plate System
27. Fixcet Spinal Facet Screw System from X-Spine Systems
28. Prophecy Pre-operative Navigational Alignment Guides from Wright Medical
29. Fusion Medical Ring Lock System
30. Apex Hip System Bipolar Head from Omnlife Science
See the full list of May FDA clearances.
Read more on FDA clearance devices:
– FDA Clears 35 Orthopedic and Spine Devices in April
– 2009 Crackdown on Pedicle Screw-Based Stabilization Systems Negatively Impacts Small, Offlabel Manufacturers
– FDA Releases 21 Draft Transparency Proposals for Public Comment
