Search Results
Found 1 results
510(k) Data Aggregation
K Number
K112986Device Name
LATERAL FUSION DEVICE
Manufacturer
INTEGRA SPINE (INTEGRA LIFESCIENCES)
Date Cleared
2012-05-01
(208 days)
Product Code
MAX, OVD
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
INTEGRA SPINE (INTEGRA LIFESCIENCES)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Integra Vu aPOD-L. Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The device is to be packed with autogenous bone graft (i.e. autograft). The Integra Vu aPOD-L Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate.
Degenerative disc disease is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment.
Device Description
The Integra Vu aPOD-L. Intervertebral Body Fusion Device consists of spinal fusion cages, optional internal buttress plates, as well as instrumentation designed specifically for the implantation of these devices. The spinal fusion cages are offered in heights of 8-16mm, lengths of 44-64mm, widths of 18mm and 23mm, and lordotic angled geometries to accommodate variations in patient anatomy. The cages include teeth on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The cages contain an open central channel for receiving bone graft to allow for bony in-growth in and around the implant. The cages can be used in combination with an optional titanium spin plate and contain radiographic markers. The devices are manufactured from Polyetheretherketone (PEEK-OPTIMA LT-1) per ASTM F2026, Titanium alloy (Ti-6Al-4V ELI) per ASTM F136, and Tantalum per ASTM F560.
Ask a Question
Page 1 of 1