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510(k) Data Aggregation
K Number
K081790Device Name
MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM
Manufacturer
Date Cleared
2008-07-24
(29 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
TRINITY ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Trinity SPMA Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal tumor, pseudoarthrosis, and failed previous fusion.
Device Description
The Single Planar Multi Axial (SPMA) Pedicle Screw System is an internal fixation device for spinal surgery consisting of rods and pedicle screw assemblies. The axle that connects the screw to the saddle allows the saddle to be adjusted in a single plane to any angle, up to 60° from the midline.
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K Number
K070295Device Name
SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
Manufacturer
Date Cleared
2007-05-21
(110 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
TRINITY ORTHOPEDICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Single Planar Multi Axial (SPMA) Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, lordosis, spinal turnor, pseudoarthrosis, and failed previous fusion.
Device Description
The SPMA Pedicle Screw System is an internal fixation device for spinal surgery consisting of rods and pedicle screw assemblies (screw, saddle, axle, locking washer and set screw). The axle that connects the screw to the saddle allows the saddle to be adjusted in a single plane to any angle, up to 60 ° from the midline. Grooves in the head of the screw and in the inferior face of the locking washer interdigitate with the splined surface of the rod to allow the assembly to be rigidly fixed in place when tightened.
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