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510(k) Data Aggregation
K Number
K133066Device Name
SPINESELECT POLYSCREW PEDICLE SCREW SYSTEM
Manufacturer
Date Cleared
2014-01-13
(108 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
SPINESELECT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The SpineSelect Polyscrew Pedicle Screw System is intended for immobilization and stabilization of the spine. The SpineSelect Polyscrew Pedicle Screw System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Device Description
The SpineSelect Polyscrew Pedicle Screw System is an implant device made from a titanium alloy TI 6Al 4V-ELI. It is to be implanted from the posterior approach. The screws are available as either solid or cannulated in diameters from 5.5-7.5 mm and in lengths from 30-55 mm. Rods are available in 5.5mm diameter either straight or precurved. The straight rods range in lengths from 30-400 mm, whereas the pre-curved rods range in length from 30-150mm. The system includes a screw assembly which includes a polyscrew (solid or cannulated), a saddle and tulip head, Rods are locked in place with a set screw. Associated instrumentation to complete the procedure are provided.
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