Safety Info - DIVERGENCE | 合法醫療器材資訊網

TheDIVERGENCE-L™Anterior/ObliqueLumbarFusionSystemplateandbonescrewcomponentsareonlytemporaryimplantsusedforthecorrectionand ...

The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System consists of temporary implants (plates and bone screws) intended for anterior screw fixation, and fusion devices (interbody cages) intended to stabilize and promote bone fusion during the normal healing process following surgical correction of disorders of the spine. The product should be implanted only by a physician thoroughly knowledgeable in the implants material and surgical aspects and instructed as to its mechanical and material applications and limitations. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone material, or INFUSE™ Bone Graft (as designated below with the DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cages), to facilitate fusion.

The DIVERGENCE-L™...