CDSCO UID IMP/MD/2022/000659_8396a03a5e9b6de92303612e03748d93_b944feceedff6c0835de0d9e34ac5f67

Intervertebral Body Fusion Device

India Medtronic Private Limited·Device Class Class D·India CDSCO·Brand: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System

Registration details

UID: IMP/MD/2022/000659_8396a03a5e9b6de92303612e03748d93_b944feceedff6c0835de0d9e34ac5f67
Device class: Class D
Brand name: DIVERGENCE-L Anterior/Oblique Lumbar Fusion System
License holder: India Medtronic Private Limited
Approving authority: CDSCO
Product information: The Divergence-L™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The Divergence-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DIVERGENCE-L Anterior/Oblique Lumbar Fusion System) at one or two contiguous levels from L2 to S1 (DIVERGENCE-L Anterior/Oblique Lumbar Fusion System). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the Divergence-L™ Anterior/Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non- operative treatment. The Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique. The Divergence-L™ Anterior/Oblique Lumbar Fusion System plate and bone screw components are indicated as a supplemental fixation device for the lumbosacral level, anterior below the bifurcation (DIVERGENCE-L Anterior/Oblique Lumbar Fusion System) of the vascular structures or anterior oblique above the bifurcation (DIVERGENCE-L Anterior/Oblique Lumbar Fusion System) of the vascular structures. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use in the temporary stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) DDD defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; 2) trauma (DIVERGENCE-L Anterior/Oblique Lumbar Fusion System); 3) tumors; 4) deformity defined as kyphosis, lordosis, or scoliosis; 5) pseudarthrosis; and/or 6) failed previous fusions. Certain sizes of the Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device may also be used with Infuse™ Bone Graft for patients diagnosed with DDD, as defined above. The device may be implanted at a single level using an Anterior Lumbar Interbody Fusion (DIVERGENCE-L Anterior/Oblique Lumbar Fusion System) approach from L2-S1. The device may also be implanted at a single level using an Oblique Lateral Interbody Fusion (DIVERGENCE-L Anterior/Oblique Lumbar Fusion System) approach from L5 to S1. The Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device is intended for use with supplemental fixation instrumentation, which has been cleared for use in the lumbar spine when used to treat DDD. Consult the labeling for the Infuse™ Bone Graft/Medtronic Interbody Fusion Device for additional information on the specific sizes of the Divergence-L™ Anterior/Oblique Lumbar Fusion System Interbody device approved for use with Infuse™ Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with Infuse™ Bone Graft. Divergence-L Anterior/Oblique Lumbar Fusion System interbody device may also be used with Infuse™ Bone Graft.