The FDA issued 39 orthopedic- and spine-related 510(k) clearances in June, according to an FDA report.
1. Clydesdale Spinal System from Medtronic Sofamor Danek
2. HBS Headless Bone Screw modification from Biopro
3. GRP Handle with HF-Connector and Instrument Accessories from MGB Endoskopiche Gerate GMBH
4. Aesculap Implant Systems S4 Spinal System
5. Graft Delivery System Model SA-6115 from Micromedics
6. Guided Growth System from Orthofix
7. Sidekick Circular Fixator System: Struts and Hinges from Wright Medical Technology
8. Retrieve Implant Cement from Parkell
9. Brainlab Knee Arthroscopy
10. Prevena Incision Management System from KCI USA
11. G-Force Peek Suture Anchor System from Wright Medical Technology
12. Medical plates, lateral plates, posterior lateral plates and olecranon plates from DePuy Orthopaedics
13. Coroent XLR Standalone System from Nuvasive
14. Ascension Ankle Fusion Plate System
15. O-Arm Imaging System from Medtronic Navigation
16. Zodiac Polyaxial Spinal Fixation System from Alphatec Spine
17. Motivation Knee System from Encore Medical
18. Compress Anti-Rotation Spindles from Biomet Manufacturing
19. Opus Speedscrew System from Arthrocare
20. Non Stick Bipolar Forceps from Egon Fauhber Surgical Instrument
21. Stryker Bipolar Forceps
22. CD Horizon Spinal System modification from Medtronic Sofamor Danek USA
23. Apex Module Hip System Biolox Delta Femoral Head from Omni Life Science
24. B-Genin and R-Genin from Berkeley Advanced Biomaterials
25. Nuvasive Vuepoint Oct System
26. Polaris Spinal System, Polaris Synergy Structue Anterior Fixation System from Biomet Spine
27. ACL Tightrope from Arthrex
28. Polaris Spinal System, Polaris Synergy Structue Anterior Fixation System from EBI
29. Sleeve with Ziploop Fixation Devices from Biomet Sports Medicine
30. Syntec Osteo-Plate and Screw Fixation from Syntec Scientific
31. Medyssey Zenius Spinal System
32. Cornerstone PSR Cervical Interbody Fusion Device from Medronic Sofamor Danek
33. Stryker Knifelight from Howmedica Osteonics
34. Wrist Arthrodonesis Nail System from Skeletal Dynamics
35. Latitude Elbow Prothesis from Tornier
36. S-LIF Intervertebral Body Fusion Device from SpineFrontier
37. Peer Prevail Cervical Interbody Device from Medtronic Sofamor Danek
38. Tyche Pedicle Screw System from Kyungwon Medical
39. Apex Modular Head, Six 28, 32 and 40 from OmniLife Science
Read the FDA report on June medical device clearances.
Read other coverage on FDA actions:
- FDA Launches New Initiative to Address Infusion Pump Safety Issues
- FDA Considers Impact of Reversing Its Decision on Knee Device
- FDA May Toughen Medical Device Approval Process
1. Clydesdale Spinal System from Medtronic Sofamor Danek
2. HBS Headless Bone Screw modification from Biopro
3. GRP Handle with HF-Connector and Instrument Accessories from MGB Endoskopiche Gerate GMBH
4. Aesculap Implant Systems S4 Spinal System
5. Graft Delivery System Model SA-6115 from Micromedics
6. Guided Growth System from Orthofix
7. Sidekick Circular Fixator System: Struts and Hinges from Wright Medical Technology
8. Retrieve Implant Cement from Parkell
9. Brainlab Knee Arthroscopy
10. Prevena Incision Management System from KCI USA
11. G-Force Peek Suture Anchor System from Wright Medical Technology
12. Medical plates, lateral plates, posterior lateral plates and olecranon plates from DePuy Orthopaedics
13. Coroent XLR Standalone System from Nuvasive
14. Ascension Ankle Fusion Plate System
15. O-Arm Imaging System from Medtronic Navigation
16. Zodiac Polyaxial Spinal Fixation System from Alphatec Spine
17. Motivation Knee System from Encore Medical
18. Compress Anti-Rotation Spindles from Biomet Manufacturing
19. Opus Speedscrew System from Arthrocare
20. Non Stick Bipolar Forceps from Egon Fauhber Surgical Instrument
21. Stryker Bipolar Forceps
22. CD Horizon Spinal System modification from Medtronic Sofamor Danek USA
23. Apex Module Hip System Biolox Delta Femoral Head from Omni Life Science
24. B-Genin and R-Genin from Berkeley Advanced Biomaterials
25. Nuvasive Vuepoint Oct System
26. Polaris Spinal System, Polaris Synergy Structue Anterior Fixation System from Biomet Spine
27. ACL Tightrope from Arthrex
28. Polaris Spinal System, Polaris Synergy Structue Anterior Fixation System from EBI
29. Sleeve with Ziploop Fixation Devices from Biomet Sports Medicine
30. Syntec Osteo-Plate and Screw Fixation from Syntec Scientific
31. Medyssey Zenius Spinal System
32. Cornerstone PSR Cervical Interbody Fusion Device from Medronic Sofamor Danek
33. Stryker Knifelight from Howmedica Osteonics
34. Wrist Arthrodonesis Nail System from Skeletal Dynamics
35. Latitude Elbow Prothesis from Tornier
36. S-LIF Intervertebral Body Fusion Device from SpineFrontier
37. Peer Prevail Cervical Interbody Device from Medtronic Sofamor Danek
38. Tyche Pedicle Screw System from Kyungwon Medical
39. Apex Modular Head, Six 28, 32 and 40 from OmniLife Science
Read the FDA report on June medical device clearances.
Read other coverage on FDA actions:
- FDA Launches New Initiative to Address Infusion Pump Safety Issues
- FDA Considers Impact of Reversing Its Decision on Knee Device
- FDA May Toughen Medical Device Approval Process