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510(k) Data Aggregation
K Number
K212389Device Name
Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF
Manufacturer
Intelivation LLC
Date Cleared
2021-10-29
(88 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Intelivation LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Advantage Lumbar System - ALIF, PLIF, TLIF is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who had six months of nonoperative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Device Description
The Advantage Lumbar – ALIF, PLIF, TLIF's implants are interbody fusion devices intended for use as an aid in spinal fixation. These hollow, rectangular implants are offered in a variety of widths, lengths, heights, and lordotic angles designed to adapt to a variety of patient anatomies. They have serrations on the superior and inferior surfaces designed for fixation, ergonomically shaped anterior edges, and flat posterior edges. Radiopaque markers have been embedded within the implants, which are designed to allow for visualization in radiographic images.
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K Number
K212185Device Name
Golden Isles Pedicle Screw System
Manufacturer
Intelivation LLC
Date Cleared
2021-08-19
(37 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Intelivation LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Golden Isles Pedicle Screw System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine as follows:
The Golden Isles System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoathrosis; and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the Golden Isles Pedicle Screw System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (1.5-S1) vertebral joint, (b) who are receiving fusions using autogenous bone graft only, (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below), and (d) who are having the device removed after the development of a solid fusion mass.
Device Description
The Golden Isles Pedicle Screw System is a spinal fixation system consisting of a variety of components including pedicle screws, modular head bodies, and various types and sizes of rods. The components are designed to be rigidly locked into a variety of configurations with each construct being appropriate for the individual patient. The Golden Isles Pedicle Screw System implant components are fabricated from medical grade titanium alloy (Ti-6Al-4V) or cobalt chrome alloy (Co-28Cr-6Mo).
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