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510(k) Data Aggregation
K Number
K140359Device Name
MAXIMIS SPINAL FIXATION SYSTEM
Manufacturer
Date Cleared
2015-01-07
(329 days)
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
VALOREM SURGICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Valorem Surgical MAXIMIS™ Pedicle Screw Fixation System is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: 1) trauma (i.e. fracture or dislocation), 2) curvatures (scoliosis, and/or lordosis) 3) spinal tumor, 4) failed previous fusion, 5) pseudoarthrosis, 6) spinal stenosis. It is not intended for pedicle screw fixation above T8. This device may be used with autograft of allograft.
Device Description
The MAXIMIS ™ Spinal Fixation System is a top-loading posterior spinal fixation system which consists of pedicle screws, rods, and set screws. The MAXIMIS TM Spinal Fixation System implant components are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.
The MAXIMIS ™ Spinal Fixation System can be used in the posterior plane providing bilateral modes of fixation.
The MAXIMIS ™ Spinal Fixation System design allows adjustment in both the sagittal and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation.
This is accomplished by means of a mobile and non-mobile housing component which houses the screw and the rod which accepts a setscrew which tightens against the rod which tightens head of the pedicle screw upon secure tightening interface of the set screw assembly with the rod.
Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the MAXIMIS ™ Spinal Fixation System implants.
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