openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L Product Usage: The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.
