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510(k) Data Aggregation
K Number
K981008Device Name
SIMAL CERVICAL STABILIZATION SYSTEM
Manufacturer
Date Cleared
1998-05-27
(70 days)
Product Code
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
TOP SURGICAL PRODUCTS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the SIMAL Cervical Stabilization Device is anterior screw fixation of the cervical spine. Fixation is done via ventral or transoral approach. Indications for Use: Spondylolisthesis(instability), fractures, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, or pseudarthrosis
Device Description
The SIMAL Cervical Stabilization System are screws and plates for anterior stabilization of the cervical spine and for anterior C2. C1 stabilization from the transoral approach.
The anterior stabilization plates have large length varieties with four lengths per segment to fit all patient sizes. For the Trans-oral approach "winged" models secure placement of articular grafts.
Both of the types of plates are anchored by titanium screws, which are available in various sizes.
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