29 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in JuneWritten by Laura Miller | July 11, 2011
The Food and Drug Administration granted 29 orthopedic- and spine-related 510(k) device clearances in June, according to an FDA report.
1. MIS Anterior Cervical Plating System from Life Spine.
2. Aptus Cannulated Compression Screws from MedArtist.
3. Tornier Insite FT Suture Anchor from Tornier.
4. Bridgepoint Spinous Process Camp- Posterior Fixation System from Alphatec Spine.
5. Avivafix Conductive Garment-Knee/Shoulder/Upper Back, Type 40 from Bio-Medical Research.
6. Zyston ARC Interbody Spacer from Biomet Spine.
7. Mini Variable System from OrthoHelix Surgical Designs.
8. TSRH Spinal System from Medtronic Sofamor Danek.
9. Equinoxe UHMWPE 12 Posterior Augment Pegged Glenoid from Exatech.
10. ExoShape Interference Fixation Device from MedShape Solutions.
11. Spineology PEEK Lumbar Interbody Fusion Device from Spineology.
12. 4CIS Solar Spine System and 4CIS Apollon Spine System from SOLCO Biomedical.
13. Aequalis Ascend Modular Reverse Shoulder System from Tornier.
14. BioSpine VBR System from Aesculap Implant Systems.
15. Apex K1 Hip Stem from OmniLife Science.
16. Maxfire Marxmen Meniscal Repair Device from Biomet.
17. Medline Epidural and Spinal Needles from Medline Industries.
18. Orthopediatrics Fracture and Osteotomy Bone Plate System from Orthopediatrics.
19. NuVasive Long Lateral Spinal System from NuVasive.
20. Astra Tech Implant System from Astra Tech.
21. Universal and Troch Entry Femoral Nailing System Line Extension from DePuy Orthopaedics.
22. Apex PS Knee System from OmniLife Sciences.
23. Aleutian Spacer System from K2M.
24. Smith & Nephew Next Generation Fully Threaded PEEK Suture Anchor from Smith & Nephew.
25. Consensus Knee System from Consensus Orthopedics.
26. Apex ARC Hip Stem from OmniLife Science.
27. Aptus Foot 3.5 System from MedArtis.
28. Corin MiniHip Femoral Stem from Corin USA.
29. Octane-C Interbody Fusion Device System from Exactech.
Read the report on June FDA clearances.
Related Articles on FDA Clearances:
35 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in May
34 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in April
56 Orthopedic and Spine Devices Receive FDA 510(k) Clearance in March
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