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K Number
K103778
Device Name
LEFORTE NEURO SYSTEM BONE PLATE
Manufacturer
JEIL MEDICAL CORPORATION
Date Cleared
2011-01-26

(30 days)

Product Code
JEY
Regulation Number
872.4760
Type
Special
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 872.4760 Bone plate.

(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.