Recently approved FDA devices
The Food and Drug Administration issued 18 spine devices 510(k) clearances in January, according to an FDA report.
1. Synthes 6.0 COCR and CPT TI-3 Rods from Synthes Spine.
2. Caliber Spacer from Globus Medical.
3. Spine Analyzer Model SAPOC from Optasia Medical.
4. Eclipse Vertebral Spacer System—Cervical from Apollo Spine.
5. Stingray Cervical Cage; Shark Implant; Bull Shark Implant Tiger Implant; Great White Implant from Omni Surgical.
6. Eclipse Vertebral Spacer System—Lumbar from Apollo Spine.
7. GPS TM, G Surgical Anterior Cervical Plate System from G Surgical.
8. Caspian Spinal System from K2M.
9. King Cobra Anterior Cervical Plate System from Eminent Spine.
10. ALIF Spinal Truss Interbody Fusion Device from 4-Web Spine.
11. VIPER System, EXPEDIUM System from DePuy Spine.
12. SP-Fix Spinous Process Fixation Plate from Globus Medical.
13. Emerald Spinal System from Mazor Surgical Technologies.
14. Exatech Proliant Polyaxial Pedicle Screw System from Exatech.
15. Kyphon Inflation Syringe from Medtronic.
16. Orthovita PEEK Spacer from Orthovita.
17. Lamenco Spinal Fixation System from Ulrich GMBH & Co.
18. CD Horizon Spinal System from Medtronic Sofamor Danek.
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female age 45, height 5"6", 145 lbds, non smoker, conservative treatments failed, (7/2007) C4/5/6 peek disc replacements,plate & screws failed fusion,
(9/2008) revision with bone replace plate and screws, (10/2009) C3/4 stand alone peek cage, (12/2010) facet joint injections C3-7, (1/2011) rhizotomy C6/7 failed, Trouble swallowing
most recent mri (7/2011) shows ajacent level issues: right neural foraminal narrowing C2/3, posterior bulge indents thecal sac at C6/7/T1 no mass effect on cord.
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