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510(k) Data Aggregation
K Number
K141695Device Name
ACROSSPINE PEDICLE SCREW SYSTEM
Manufacturer
Date Cleared
2014-12-30
(189 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ARTHRO-DIF
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Acrosspine Pedicle Screw System is intended for noncervical pedicle fixation from the T1 to S1 vertebrae in skeletally mature patients as an adjunct to fision for the following indications: degenerative disc disease (defined as back. pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthess: trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor, pseudarthrosis: and failed previous fusion.
Device Description
The Arthro-DIF Acrosspine Pedicle Screw System is an implant device made from an unalloyed titanium and 6Al4V Titanium Alloy. It is to be implanted from the posterior approach. The screws are available in 5.5, 6.5 and 7.5mm diameters and in lengths from 35-60 mm. The screws are available as polyaxial screws. All rods are available in 5.5mm diameter with curved rod in lengths from 40-100 mm, and straight rods from 150-300mm.
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