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510(k) Data Aggregation
K Number
K120074Device Name
FOUNDATION SPINAL SYSTEM
Manufacturer
Date Cleared
2012-03-14
(64 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
THE SKELETAL DESIGN PARTNERSHIP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Foundation Spinal System is intended for thoracolumbar (T4-L4) anterolateral screw fixation and posterior, non-cervical (T1-S1) pedicle and non-pedicle fixation to provide immobilization and stabilization in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion.
Device Description
The Foundation Spinal System consists of rods, hooks, staple plates, monoaxial and multiaxial screws with set screws and crosslinks with fastening set screws. Rods are available either straight or pre-contoured in a variety of lengths. Hooks and staple plates are offered in a variety of sizes. Solid and cannulated screws are available in standard and reduction versions in a variety of diameter-length combinations to accommodate differing patient anatomy.
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