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510(k) Data Aggregation
K Number
K161680Device Name
MEDICON Spinal Spreading Systems
Manufacturer
MEDICON EG
Date Cleared
2017-03-24
(280 days)
Product Code
GZT
Regulation Number
882.4800Why did this record match?
Applicant Name (Manufacturer) :
MEDICON EG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MEDICON Spinal Spreading Systems are used to spread soft tissue and maintain surgical access in spine surgery and may only be used by surgeons with proper training and adequate experience in spine surgery.
Device Description
The MEDICON Spinal Spreading System is made up of multiple reusable manual spreader systems. The spreaders include components for all approaches in spine surgery, including those specifically for cervical spine surgery, as well as inter-laminar, trans-laminar, extra-foraminal and dorsolateral approaches. The multiple components support classic and minimally invasive procedures. The components are made from a radiolucent x-ray compatible material, from titanium, some from stainless steel, and some from anodized aluminum.
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