Degenerative Disc Disease Clinical Trial
Official title:
Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device
This study is a post-market clinical follow-up study. A post-market, prospective clinical trial will be conducted. The data collected from this study will serve the purpose of confirming safety and performance of the FLXfit™ implant.
As detailed by Expanding Orthopedics Inc., the FLXfit™ is an expandable, articulated
interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide
structural stability in skeletally mature individuals following total or partial discectomy.
The FLXfit™ is a unique titanium cage which articulates laterally as well as expands in
height. This enables larger footprint support as well as restoration of disc height and
lordotic angle correction. A bullet-nose design facilitates self-distraction and ease of
insertion. The open architecture of the device allows it to be packed with autogenous bone
graft.
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