The Food and Drug Administration granted 16 spine-related clearances in November.
1. Frontier Sadl Interbody Fusion Device from Frontier Medical Devices.
2. Lite Decompression System from Stryker Spine.
3. Dymaxeon Spine System from B2B Spine.
4. Pioneer Posterior Occipito-Cervico-Thoracitc System from Pioneer Surgical Technology.
5. Vertiflex Direct Compression System from Vertiflex.
6. Pro-Link Cervical Spacer System from Life Spine.
7. CD Horizon Spire Z Spinal System from Medtronic Sofamor Danek.
8. Incite Anchored Cervical Interbody Fusion Device from Incite Innovation.
9. Synthes Matrixmadible Plate and Screw System from Synthes.
10. Zou Anterior Lumbar Plate System from Corelink.
11. Loqteq Distal Lateral Femur Plate, Cortical Screw from Aap Implantante.
12. S-Lok PSS System from Spinal USA.
13. Viceroy Spinal System from Torrey Spine.
14. Illico FS Facet Fixation System from Alphatec Spine.
15. Construx Mini PEEK TI Spacer System from Orthofix.
16. PrimaLIF TM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System from OsteoMed.
More Articles on FDA Clearances:
24 Spine Devices Receive FDA 510(k) Clearance in October
13 Spine Devices Receive FDA 510(k) Clearance in September
23 Spine Devices Receive FDA 510(k) Clearance in August
1. Frontier Sadl Interbody Fusion Device from Frontier Medical Devices.
2. Lite Decompression System from Stryker Spine.
3. Dymaxeon Spine System from B2B Spine.
4. Pioneer Posterior Occipito-Cervico-Thoracitc System from Pioneer Surgical Technology.
5. Vertiflex Direct Compression System from Vertiflex.
6. Pro-Link Cervical Spacer System from Life Spine.
7. CD Horizon Spire Z Spinal System from Medtronic Sofamor Danek.
8. Incite Anchored Cervical Interbody Fusion Device from Incite Innovation.
9. Synthes Matrixmadible Plate and Screw System from Synthes.
10. Zou Anterior Lumbar Plate System from Corelink.
11. Loqteq Distal Lateral Femur Plate, Cortical Screw from Aap Implantante.
12. S-Lok PSS System from Spinal USA.
13. Viceroy Spinal System from Torrey Spine.
14. Illico FS Facet Fixation System from Alphatec Spine.
15. Construx Mini PEEK TI Spacer System from Orthofix.
16. PrimaLIF TM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System from OsteoMed.
More Articles on FDA Clearances:
24 Spine Devices Receive FDA 510(k) Clearance in October
13 Spine Devices Receive FDA 510(k) Clearance in September
23 Spine Devices Receive FDA 510(k) Clearance in August