The Food and Drug Administration issued 26 orthopedic- and spine-related 510(k) clearances in July, according to an FDA report.
1. Titlock Pedicle Screw System from Genesys Spine
2. Spine Smith Cynch Spinal System from Spine Smith Partners
3. Ceruleau Electrosurgical Probe from NuOrtho Surgical
4. Radius Spinal System modification from Stryker Spine
5. Spondylos Spinal Fixation System from Allure Spine
6. Ascension Ankle Fusion Nail System from Ascension Orthopedics
7. Aesculap Monomax Absorbable Suture
8. Pediatric Head-Spine Coil from Shanghai Chenguang Medical Technology
9. Smith & Nephew MDF Modular Sleeve
10. Facet Screw System from NuVasive
11. Juliet OL from Spineart
12. Reporcessed Restep Compression Sleeves from Ascent Healthcare Solutions
13. Fixpine II System from DIO Medical
14. Aesculap Implant Systems SIBD Spinal System
15. Alphatec Spine Anterior Lumbar Plating System
16. Venus Basic Spinal Fixation System from L&K Biomed
17. Impix Lumbar Interbody Device from Medicrea Technologies
18. Closed Fusion Plate, MTP Plate, Talus Plate from DePuy Orthopaedics
19. S4 Cervical Occipital Plate Spinal System from Aesculap Implant System
20. TGS Unicompartmental Knee Arthroplasty Modular Tibia System from Aesculap Implant System
21. Pro-Toe Vo Hammertow Implant System from Wright Medical Technology
22. Firebird Spinal Fixation System from Blackstone Medical
23. Romeo Posterior Osteosynthesis System from Spineart
24. Endoskeleton TC from Titan Spine
25. Arthrex Biowire
26. Vega Knee System from Aesculap Implant System
Read the release on FDA 510(k) July clearances.
Read other coverage on the FDA:
- 39 Orthopedic and Spine Devices Receive FDA Clearance in June
- FDA Panel Votes to Recommend Approval for Medtronic's Amplify Spine Device
- 2009 Crackdown on Pedicle Screw-Based Stabilization System Negatively Impacts Small, Offlabel Manufacturers
1. Titlock Pedicle Screw System from Genesys Spine
2. Spine Smith Cynch Spinal System from Spine Smith Partners
3. Ceruleau Electrosurgical Probe from NuOrtho Surgical
4. Radius Spinal System modification from Stryker Spine
5. Spondylos Spinal Fixation System from Allure Spine
6. Ascension Ankle Fusion Nail System from Ascension Orthopedics
7. Aesculap Monomax Absorbable Suture
8. Pediatric Head-Spine Coil from Shanghai Chenguang Medical Technology
9. Smith & Nephew MDF Modular Sleeve
10. Facet Screw System from NuVasive
11. Juliet OL from Spineart
12. Reporcessed Restep Compression Sleeves from Ascent Healthcare Solutions
13. Fixpine II System from DIO Medical
14. Aesculap Implant Systems SIBD Spinal System
15. Alphatec Spine Anterior Lumbar Plating System
16. Venus Basic Spinal Fixation System from L&K Biomed
17. Impix Lumbar Interbody Device from Medicrea Technologies
18. Closed Fusion Plate, MTP Plate, Talus Plate from DePuy Orthopaedics
19. S4 Cervical Occipital Plate Spinal System from Aesculap Implant System
20. TGS Unicompartmental Knee Arthroplasty Modular Tibia System from Aesculap Implant System
21. Pro-Toe Vo Hammertow Implant System from Wright Medical Technology
22. Firebird Spinal Fixation System from Blackstone Medical
23. Romeo Posterior Osteosynthesis System from Spineart
24. Endoskeleton TC from Titan Spine
25. Arthrex Biowire
26. Vega Knee System from Aesculap Implant System
Read the release on FDA 510(k) July clearances.
Read other coverage on the FDA:
- 39 Orthopedic and Spine Devices Receive FDA Clearance in June
- FDA Panel Votes to Recommend Approval for Medtronic's Amplify Spine Device
- 2009 Crackdown on Pedicle Screw-Based Stabilization System Negatively Impacts Small, Offlabel Manufacturers