11 Spine Devices Receive FDA 510(k) Clearance in January FeaturedWritten by Laura Miller | Tuesday, 12 February 2013 16:55
The Food and Drug Administration granted 11 spine-related device clearances in January.
1. Instinct Java System from Zimmer Spine.
2. K7C Spacer from K7.
3. Mega 5.5 Spine System from LSK Biopartners.
4. Falcon Spacer from Synthes.
5. Spinal Elements Cervical Intervertebral Body Fusion System from Spinal Elements.
6. Caber Spine Technologies TLS 5.0 Interbody Cage from Caber Spine Technologies.
7. AccuLIF TL and PL Cage from Coalign Innovations.
8. Innesis PEEK Cage from BK Meditech.
9. Caliber Spacers from Globus Medical.
10. Medyssey Cannulated Pedicle Screw from Medyssey.
11. VariLift-C from Wenzel Spine.
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