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510(k) Data Aggregation
K Number
K111512Device Name
BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM
Manufacturer
THOMPSON MIS INC
Date Cleared
2011-10-26
(147 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
THOMPSON MIS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is indicated for use in skeletally mature patients who have had six months of non-operative treatment. The in biololially maters patte treatment of degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s).
The BoneBac™ T-PLIF Intervertebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine and autogenous bone graft to facilitate fusion.
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies.
Device Description
The BoneBac™ T-PLIF Intervertebral Body Fusion Device is a spinal intervertebral body fusion device system comprised of implants with a variety of lengths, widths, and heights to accommodate patient anatomy. The implants are made of Solvay Zeniva ZA-500 PEEK (ASTM F2026). The devices have raised contours on the superior and inferior surfaces that will resist device movement following implant. The devices contain radiographic markers to enable fluoroscopic visualization.
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