Search Results
Found 2 results
510(k) Data Aggregation
K Number
K103383Device Name
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
Manufacturer
Date Cleared
2011-02-17
(91 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
SPARTEK MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion with autogenous bone graft 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 Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a single use device for monoand multi-segmented stabilization of the lumbar and thoracic vertebrae to facilitate fusion, per the indications for use. The system consists of post and fixed head screws, washers, rods, set screws, and locking nuts.
Ask a Question
Ask a specific question about this device
K Number
K094002Device Name
SPARTEK VARIABLE ANGLE PEDICLE SCREW POSTERIOR FUSION SYSTEM
Manufacturer
Date Cleared
2010-05-07
(130 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
SPARTEK MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is intended for immobilization and stabilization of the thoracic, lumbar, and sacral spine in skeletally mature patients as an adjunct to fusion with autogenous.bone graft 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, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
Device Description
The Spartek™ Variable Angle Pedicle Screw Posterior Fusion System is a single use device for mono- and multi-segmented stabilization of the lumbar and thoracic vertebrae to facilitate fusion, per the indications for use. The system consists of post and fixed head screws, washers, rods, set screws, and locking nuts.
Ask a Question
Ask a specific question about this device
Page 1 of 1