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510(k) Data Aggregation
K Number
K092901Device Name
EPICAGE INTERBODY FUSION DEVICE
Manufacturer
R TREE INNOVATIONS
Date Cleared
2010-04-28
(219 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
R TREE INNOVATIONS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Epicage Interbody Fusion Device is intended for interbody fusion procedures and is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the device is intended to be used with supplemental posterior fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone.
Device Description
The Epicage Interbody Fusion Device is a PEEK implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is designed with openings for bone growth and fusion. The rib allow for flexure of the device during insertion. The device is available in two lengths to accommodate various patients' anatomy. Each of these sizes is available in 4 heights ranging from 8mm to 14mm in 2mm increments.
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