44 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in FebruaryWritten by Laura Miller | March 06, 2012
The Food and Drug Administration granted 44 orthopedic- and spine-related 510(k) clearances in February, according to an FDA report.
1. Pass LP Spinal from Medicrea International.
2. Klassic Knee System from Total Joint Orthopedics.
3. Synthes USS Connectors from Synthes Spine.
4. Savannah Technologies Spinal System from Savannah Technologies.
5. Conserve Thin Shell from Wright Medical Technologies.
6. Coral Spinal System from Theken Spine.
7. ConforMIS iTotal CR Knee Replacement System from ConforMIS.
8. Metatarsal Decompression Implant Surgical Implant Set from Solana Surgical.
9. Hemi Phallangeal Implant Surgical Instrument Set from Solana Surgical.
10. CheckMate Matatarso-Phalangeal Arthrodesis System from ArthroSurface.
11. Perimeter Interbody Fusion Device from Medtronic Sofamor Danek.
12. Corin Trinity Acetabular System Ecima Liners from Corin U.S.A.
13. Pathway Avd from Custom Spine.
14. Callos Promodel Bone Void Filler, Skaffold from Skeletal Kinetics.
15. Ortho Solutions Extremity Fixation Implants for Osteosynthesis from Ortho Solutions.
16. DePuy Pulse Thoracolumbar Screw System from Medos International SARL.
17. CD Horizon Voyager Spinal System from Medtronic Sofamor Danek.
18. SpineVu Endoscopic Spine System from Spine View.
19. CoFlex-F from Paradigm Spine.
20. PolyFuse—NeuroBone from ATPAC Medical.
21. S2 Femoral A/R Nail from Homedica Osteonics.
22. ConforMIS iTotal Cruciate Retaining Knee Replacement System from ConforMIS.
23. Focus Spinal System from L&K Biomed.
24. Eaum Total Knee System from Corentec.
25. Comprehensive Reverse Shoulder-Mini Baseplate from Biomet.
26. Icon Modular Pedicle Screw System from Orthofix.
27. Eclipse Vertebral Spacer System — Cervical from Apollo Spine.
28. Arena-C Cervcal Intervertebral Body Fusion System from SpineFrontier.
29. Hemasorb Resorbable Hemostatic Bone Putty from OrthoCon.
30. Arthrex Knotless SutureTak Anchor from Arthrex.
31. Acu-cut Vertebral Augmentation System from Ascendx Spine.
32. Wagner Cone Prosthesis System from Zimmer GMBH.
33. KneeTec Patellar Component from Tornier.
34. SMR Modular Glenoid-Metal-Back from Lima.
35. Linear Hip System, Size 5 from Encore Medical.
36. Sintea Plustek Anterior Cervical Plate System from Sintea Pulstek.
37. Journey II Deep Dished Articular Inserts from Smith & Nephew.
38. MectaLIF Transforaminal from Medacta.
39. Apex Revision Knee Systems from Omni Life Science.
40. Dynnail Ankle Arthrodesis Nail from Medshape.
41. Spineology PEEK Lumbar Interbody Fusion Drive from Spineology.
42. 7MM LCP ULNAR Osteotomy System from Synthes.
43. Healix Advance BR Anchor from DePuy Mitek.
44. Vanguard Complete Knee System from Biomet.
More Articles on FDA Clearances:
43 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in January
56 Orthopedic & Spine Devices Receive FDA Clearance in December
39 Orthopedic & Spine Devices Receive FDA 510(k) Clearance in November
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