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510(k) Data Aggregation
K Number
K152501Device Name
Spinal Jaxx Interbody Fusion Device
Manufacturer
NEUROPRO SPINAL JAXX, INC.
Date Cleared
2016-06-29
(302 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
NEUROPRO SPINAL JAXX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The Spinal Jaxx Interbody Fusion device is a lumbar intervertebral spacer intended to provide structural stability in a skeletally mature individual based on the surgical intervention by the surgeon. The physician can insert it into the diseased disc space and adjust the height of the device as desired to create near normal disc height. The implants are made from PEEK Optima LT1, a medical grade titanium alloy, CP titanium and Nitinol. Implants are available in various sizes to accommodate patient anatomy. Instruments are made from stainless steel, aluminum, Nitinol, and silicone rubber.
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