DevicePMAs@therightstef:P040006_S000 / 0-8 JSONTXT

Approval for the charite artificial disc. The device is indicated for spinal arthroplasty in skeletally mature patients with degenerative disc disease (ddd) at one level from l4-s1. Ddd is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ddd patients should have no more than 3 mm of spondylolisthesis at the involved level. Patients receiving the charite artificial disc should have failed at least six months of conservative treatment prior to implantation of the charite artificial disc.

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PMA_MER 1 (1)