12 Spine Devices Receive FDA 510(k) Clearance in JuneWritten by Laura Miller | July 12, 2011
The Food and Drug Administration granted 510(k) clearances to 12 spine-related devices in June, according to an FDA report.
1. MIS Anterior Cervical Plating System from Life Spine.
2. Aptus Cannulated Compression Screws from MedArtist.
3. Bridgepoint Spinous Process Camp- Posterior Fixation System from Alphatec Spine.
4. Zyston ARC Interbody Spacer from Biomet Spine.
5. TSRH Spinal System from Medtronic Sofamor Danek.
6. Spineology PEEK Lumbar Interbody Fusion Device from Spineology.
7. 4CIS Solar Spine System and 4CIS Apollon Spine System from SOLCO Biomedical.
8. BioSpine VBR System from Aesculap Implant Systems.
9. Medline Epidural and Spinal Needles from Medline Industries.
10. NuVasive Long Lateral Spinal System from NuVasive.
11. Aleutian Spacer System from K2M.
12. Octane-C Interbody Fusion Device System from Exactech.
Read the report of June FDA clearances.
Related Articles on FDA Clearances:
15 Spine Devices Receive FDA Clearance in May
13 Spine Devices Receive FDA Clearance in April
22 Spine Devices Receive FDA Clearance in March
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