Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions, according to a June 12 news release.
THe FDA’s 510(k) clearance was based on safety testing that found FlareHawk implants met established ASTM standards for MRI compatibility. Now patients who had the device implants can be safely scanned under conditions outlined by Accelus.
The FlareHawk system is designed with a PEEK shell, a titanium surface technology embedded into the shell substrate and an internal titanium shim. More than 32,000 FlareHawk cages have been implanted across 25 countries.
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