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510(k) Data Aggregation
K Number
K024125Device Name
HALM ZIELKE INSTRUMENTATION SYSTEM
Manufacturer
MICOMED ORTHO GMBH
Date Cleared
2003-09-22
(280 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
MICOMED ORTHO GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Halm Zielke Instrumentation System is an anterior spinal fixation system indicated for spinal deformities in the thoracic and lumbar spine such as scoliosis, kyphosis, lordosis and thoracolumbar spinal instability caused by fracture.
Device Description
The principal components of the Micomed Halm Zielke Instrumentation System, which is a low profile spinal fixation system, are as follows: Halm and HC plates, screws, threaded rods, standard hex nuts for threaded rods, fluted rods, and vertebral clamps (double and single hole). Additional instrumentation includes: awls, wrenches, insertion instruments for rods and screws, vertebral and end vertebra screws, top loading screws and set screws, rod pushers and rod benders, grip and compression tongs, rod cutter and distraction instrument. The principal components of the Micomed Halm Zielke Instrumentation are used in the following manner: First, the most cranial and caudal Halm plates are each attached to the lateral aspect of the vertebral body with two screws (countersunk, Zielke), and then additional plates are attached as needed. The threaded rod is then connected to the top of the Zielke screws and anchored with the standard hex nuts. Once the threaded rod is properly connected to the Halm plates, partial correction of the scoliotic deformity is performed before attaching the pre-bent fluted rod by closing the lid of the Halm plate and securing with the head screws. The secured fluted rod can then be rotated around its longitudinal axis to achieve and appropriate level of derotation and relordosation. If this system is used in the thoracic spine, rod rotation is performed in reverse to produce or enhance physiological kyphosis. Additionally, segmental compression or distraction can be used to increase or decrease lordosis or kyphosis, as desired.
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K Number
K021275Device Name
MICOMED POSTERIOR DOUBLEROD SYSTEM
Manufacturer
MICOMED ORTHO GMBH
Date Cleared
2002-07-18
(87 days)
Product Code
MNI, KWP, MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
MICOMED ORTHO GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Micomed Posterior Doublerod System is a pedicle screw system indicated for the treatment of severe spondyloisthesis (Grades 3 and 4) at the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The Micomed Posterior Doublerod System is a pedicle screw system 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 of deformities of the thoracic, lumbar, and sacral spine: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
When used as a non-pedicle screw fixation system, the Micomed Posterior Doublerod System is also intended for scoliotic, lordotic deformities such as scoliosis, Scheuermann's disease, degernerative disk disease defined as back pain of discogenic origin with degeneration of the disk confirmed by patient history and radiographic studies, and fractures of the posterior thoracolumbar spine from levels T4 to S1.
Device Description
The Micomed Posterior Doublerod System is a low profile, top loading spinal fixation system available in titanium and stainless steel. The system consists of pedicle screws, polyaxial screws*, open and closed hooks, and fluted and threaded rods. A set of instruments is available for use with the Micomed Posterior Doublerod System. * polyaxial screws are only available in titanium
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